{"name":"HospitalRoom.org Standards Index","description":"Machine-readable index of the standards, regulations, and guidance documents profiled by HospitalRoom.org. Summaries for orientation only — consult each publisher's official text.","url":"https://hospitalroom.org/standards","license":"CC BY 4.0","attribution":"Attribute 'HospitalRoom.org' with a link back to https://hospitalroom.org/standards","note":"This index licenses HospitalRoom.org's summaries only. The underlying standards are the property of their publishers.","generated":"2026-11-12T02:28:16.010Z","version":"1.0","count":21,"standards":[{"slug":"fgi-guidelines","short":"FGI Guidelines","fullName":"FGI Code for Planning and Design of Hospitals (formerly Guidelines for Design and Construction of Hospitals)","publisher":"Facility Guidelines Institute","publisherUrl":"https://fgicodes.org/codes/editions/","latest":"2026 FGI Code for Planning and Design of Hospitals (released Aug 31, 2026); 2022 Guidelines still adopted in many jurisdictions","editionChecked":"2026-10-26","domain":"Design","scope":"The FGI Guidelines are the de facto reference for the physical design and construction of hospital facilities in the United States. They set minimum requirements for room area, clearances, headwall configuration, plumbing, and unit organization, and are adopted by reference into many state health department codes.","appliesTo":["Minimum clear floor area for med-surg, ICU, PACU, and isolation rooms","Clearances around the head, foot, and transfer sides of the bed","Single-patient-room defaults in new construction","Family and caregiver zones within the room"],"keyRequirements":[{"label":"ICU minimum area (2022 Guidelines)","detail":"200 sq ft clear floor area for new single-patient ICU rooms."},{"label":"Med-surg minimum area (2022 Guidelines)","detail":"120 sq ft clear floor area for single-patient rooms (new construction)."},{"label":"Bed clearances","detail":"Minimum clear dimensions are set around the sides and foot of the bed and vary by room type; check the edition adopted in your jurisdiction for exact values."},{"label":"Single-occupancy default","detail":"New construction defaults to single-patient rooms unless otherwise justified."}],"status":"Consensus document adopted by reference by many US states and authorities; which edition applies depends on the jurisdiction.","caveats":["Starting with 2026, FGI publishes enforceable minimums as the FGI Code and moves explanatory material to separate subscription Handbooks.","Area figures shown are from the 2022 Guidelines and have not been re-checked against the 2026 Code text here."],"aliases":["FGI Guidelines for Design and Construction of Hospitals","FGI Hospital Code","FGI Guidelines","FGI Code","Facility Guidelines Institute","FGI"],"url":"https://hospitalroom.org/standards/fgi-guidelines","sources":[{"label":"FGI editions","url":"https://fgicodes.org/codes/editions/","note":"publisher"},{"label":"FGI launches 2026 FGI Codes and Handbooks (press release, Aug 31, 2026)","url":"https://fgicodes.org/press-release/fgi-launches-2026-fgi-codes-and-handbooks-and-introduces-fgi-onesource/","note":"publisher"}],"relatedStandards":["ashrae-170","ies-rp-29"],"relatedFrameworks":[{"slug":"nurse-call-routing-readiness","url":"https://hospitalroom.org/frameworks/nurse-call-routing-readiness"}]},{"slug":"ashrae-170","short":"ASHRAE 170","fullName":"ANSI/ASHRAE/ASHE Standard 170 — Ventilation of Health Care Facilities","publisher":"ASHRAE","publisherUrl":"https://ashrae.org","latest":"170-2025 (supersedes 170-2021)","editionChecked":"2026-10-26","domain":"Ventilation","scope":"Standard 170 specifies minimum ventilation requirements for hospital, outpatient, and residential health-care spaces. It defines air changes per hour (ACH), pressure relationships, filtration efficiency, and temperature/humidity ranges for every functional space in a hospital, including the patient room and airborne infection isolation room.","appliesTo":["Total and outdoor air changes per hour by room type","Pressure relationship (positive, negative, neutral) versus adjacent spaces","Filtration MERV / HEPA requirements","Temperature and relative humidity ranges"],"keyRequirements":[{"label":"Space-by-space table","detail":"Total and outdoor air changes, pressure relationship, filtration, and temperature/humidity are set per space type; values have changed between editions."},{"label":"AIIR (isolation)","detail":"≥ 12 ACH new / ≥ 6 existing; negative to corridor by ≥ 0.01 in. w.c. (consistent with CDC's 2003 environmental infection control guideline; confirm against the adopted 170 edition)"},{"label":"Protective environment room","detail":"≥ 12 ACH; positive to corridor; HEPA-filtered supply. (consistent with CDC's 2003 environmental infection control guideline; confirm against the adopted 170 edition)"}],"status":"Referenced by FGI Guidelines and by CDC infection-control guidance.","caveats":["Authorities having jurisdiction adopt and enforce different editions of Standard 170; confirm which edition applies."],"aliases":["ANSI/ASHRAE/ASHE Standard 170","ASHRAE Standard 170","ASHRAE 170"],"url":"https://hospitalroom.org/standards/ashrae-170","sources":[{"label":"ASHRAE Standard 170 — publisher page","url":"https://www.ashrae.org/technical-resources/standards-and-guidelines","note":"publisher"},{"label":"ANSI/ASHRAE/ASHE Standard 170-2025 (ASHE)","url":"https://www.ashe.org/standard170-2025","note":"publisher"}],"relatedStandards":["fgi-guidelines","cdc-environmental-infection"],"relatedFrameworks":[]},{"slug":"iec-60601-1-8","short":"IEC 60601-1-8","fullName":"IEC 60601-1-8 — Requirements, tests and guidance for alarm systems in medical electrical equipment","publisher":"International Electrotechnical Commission","publisherUrl":"https://iec.ch","latest":"Edition 2.2 (2020)","editionChecked":"2026-10-26","domain":"Devices","scope":"60601-1-8 is the collateral safety standard that governs how audible and visual alarms behave on medical devices. It defines alarm priorities, sound characteristics, information content, and requirements for delegating and logging alarms — the reason patient monitors across vendors sound broadly similar.","appliesTo":["Alarm priorities (high, medium, low, information)","Alarm-signal delegation to a distributed system","Alarm inactivation states and their indication","Alarm-system logs and history"],"keyRequirements":[{"label":"Priority levels","detail":"Three action-required priorities plus information signals, with distinct visual and auditory cues."},{"label":"Distributed alarms","detail":"Covers distributed alarm systems, including how a failure of remote communication is handled and indicated; consult the official text for exact obligations."},{"label":"Alarm log","detail":"Addresses alarm-system logging of alarm conditions; the official text sets what must be recorded."}],"status":"FDA recognized consensus standard (recognition 5-131, Edition 2.2 consolidated version, 2020-07).","caveats":[],"aliases":["IEC 60601-1-8","60601-1-8"],"url":"https://hospitalroom.org/standards/iec-60601-1-8","sources":[{"label":"IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 — official listing","url":"https://webstore.iec.ch/en/publication/67388","note":"publisher"},{"label":"FDA Recognized Consensus Standards database","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=60601-1-8","note":"regulator"}],"relatedStandards":["iec-60601-1","iec-60601-2-27"],"relatedFrameworks":[{"slug":"alarm-path-readiness","url":"https://hospitalroom.org/frameworks/alarm-path-readiness"}]},{"slug":"iec-60601-1","short":"IEC 60601-1","fullName":"IEC 60601-1 — General requirements for basic safety and essential performance","publisher":"International Electrotechnical Commission","publisherUrl":null,"latest":"Edition 3.2 (2020)","editionChecked":"2026-10-26","domain":"Devices","scope":"The base standard for the safety of medical electrical equipment. It defines requirements for electrical, mechanical, and thermal safety, plus the essential performance a device must retain during single-fault conditions. Medical electrical equipment at the bedside is typically evaluated against 60601-1 or a regional adoption of it.","appliesTo":["Isolation, leakage current, and grounding of bedside equipment","Essential performance under single-fault conditions","Risk management alignment with ISO 14971"],"keyRequirements":[],"status":null,"caveats":["A fourth edition is in development at IEC; it has not been published. Edition 3.2 remains the consolidated current text."],"aliases":["IEC 60601-1","60601-1"],"url":"https://hospitalroom.org/standards/iec-60601-1","sources":[{"label":"IEC 60601-1:2005+AMD1:2012+AMD2:2020 — official listing","url":"https://webstore.iec.ch/publication/67497","note":"publisher"}],"relatedStandards":["iec-60601-1-8"],"relatedFrameworks":[]},{"slug":"iec-60601-2-27","short":"IEC 60601-2-27","fullName":"IEC 60601-2-27 — Particular requirements for ECG monitoring equipment","publisher":"International Electrotechnical Commission","publisherUrl":null,"latest":"Edition 3.0 (2011-03), with Corrigendum 1 (2012)","editionChecked":"2026-10-26","domain":"Devices","scope":"The particular safety and performance standard for continuous ECG monitoring devices, covering electrode configurations, arrhythmia detection performance, and lead-off detection.","appliesTo":["Continuous 3-, 5-, and 12-lead ECG monitors","Arrhythmia and pacemaker-pulse detection performance"],"keyRequirements":[],"status":null,"caveats":["IEC shows a revision under development; check the publisher page for a newer edition."],"aliases":["IEC 60601-2-27","60601-2-27"],"url":"https://hospitalroom.org/standards/iec-60601-2-27","sources":[{"label":"IEC 60601-2-27:2011 — official listing","url":"https://webstore.iec.ch/publication/2638","note":"publisher"}],"relatedStandards":["iec-60601-1"],"relatedFrameworks":[]},{"slug":"iso-ieee-11073","short":"ISO/IEEE 11073","fullName":"ISO/IEEE 11073 — Health informatics — Point-of-care medical device communication","publisher":"ISO / IEEE","publisherUrl":null,"latest":"Ongoing; -10101 nomenclature revised regularly","domain":"Interoperability","scope":"The 11073 family standardizes how medical devices describe themselves and their measurements. -10101 is the nomenclature (a controlled vocabulary of what a value means), and -10201/-20601 govern device communication. It is the vendor-neutral vocabulary that lets a Philips monitor and a Dräger ventilator report a heart rate the same way to an EHR.","appliesTo":["Semantic identifiers for device measurements","Device-EHR integration via middleware gateways"],"keyRequirements":[],"status":null,"caveats":[],"aliases":["ISO/IEEE 11073-10101","ISO/IEEE 11073","IEEE 11073","11073-10101"],"url":"https://hospitalroom.org/standards/iso-ieee-11073","sources":[{"label":"IEEE 11073 standards family","url":"https://standards.ieee.org/searchresults/?q=11073","note":"IEEE catalog"},{"label":"ISO/IEEE 11073-10101:2020","url":"https://www.iso.org/standard/79338.html","note":"ISO"}],"relatedStandards":["hl7-fhir","hl7-v2"],"relatedFrameworks":[{"slug":"device-integration-readiness","url":"https://hospitalroom.org/frameworks/device-integration-readiness"}]},{"slug":"hl7-fhir","short":"HL7 FHIR","fullName":"HL7 Fast Healthcare Interoperability Resources (FHIR) R4","publisher":"HL7 International","publisherUrl":"https://hl7.org/fhir","latest":"R4 (US regulatory baseline); R5 published; R6 in ballot (6.0.0-ballot4), not final","editionChecked":"2026-10-26","domain":"Interoperability","scope":"FHIR is the modern REST/JSON standard for healthcare data exchange. In the US, ONC's Cures Act rule mandates FHIR R4 APIs for certified EHRs, using the USCDI dataset. FHIR is what the smart room usually speaks to the outside world after HL7 v2 speaks to the bedside.","appliesTo":["EHR patient-facing and provider-facing APIs","Observation, Device, Encounter, and Patient resources","SMART-on-FHIR app launches inside the EHR"],"keyRequirements":[],"status":"Mandated for US ONC-certified EHRs (R4) under the 21st Century Cures Act.","caveats":["R6 is a ballot release; HL7's plan schedules further normative ballots before final publication."],"aliases":["HL7 FHIR R4","HL7 FHIR","FHIR R4","FHIR"],"url":"https://hospitalroom.org/standards/hl7-fhir","sources":[{"label":"HL7 FHIR R4 specification","url":"https://hl7.org/fhir/R4/","note":"publisher"},{"label":"HL7 FHIR (latest)","url":"https://hl7.org/fhir/","note":"current build"},{"label":"FHIR R6 ballot","url":"https://hl7.org/fhir/6.0.0-ballot4/","note":"ballot"},{"label":"ONC Cures Act Final Rule","url":"https://www.healthit.gov/topic/oncs-cures-act-final-rule","note":"US regulation"}],"relatedStandards":["hl7-v2","uscdi","iso-ieee-11073"],"relatedFrameworks":[{"slug":"device-integration-readiness","url":"https://hospitalroom.org/frameworks/device-integration-readiness"}]},{"slug":"hl7-v2","short":"HL7 v2","fullName":"HL7 Version 2 messaging standard","publisher":"HL7 International","publisherUrl":null,"latest":"v2.9.1 (ANSI/HL7 V2.9.1-2024, published Sept 2024)","editionChecked":"2026-10-26","domain":"Interoperability","scope":"HL7 v2 is the pipe-and-hat delimited messaging standard that carries most bedside device and lab traffic inside hospitals today. It predates FHIR by decades and remains dominant for ADT, orders, results, and device observations.","appliesTo":["ADT (admit / discharge / transfer) feeds","Order, result, and device observation messages","Interface engines and integration middleware"],"keyRequirements":[],"status":null,"caveats":[],"aliases":["HL7 v2.x","HL7 v2","HL7 Version 2"],"url":"https://hospitalroom.org/standards/hl7-v2","sources":[{"label":"HL7 v2 product family","url":"https://www.hl7.org/implement/standards/product_brief.cfm?product_id=185","note":"publisher"},{"label":"HL7 Version 2.9.1 product brief","url":"https://www.hl7.org/implement/standards/product_brief.cfm?product_id=649","note":"publisher"}],"relatedStandards":["hl7-fhir","iso-ieee-11073"],"relatedFrameworks":[{"slug":"device-integration-readiness","url":"https://hospitalroom.org/frameworks/device-integration-readiness"}]},{"slug":"uscdi","short":"USCDI","fullName":"United States Core Data for Interoperability","publisher":"ONC (Office of the National Coordinator for Health IT)","publisherUrl":null,"latest":"USCDI v7 (July 2026)","editionChecked":"2026-10-26","domain":"Data","scope":"USCDI is the minimum data set that ONC-certified health IT must exchange. It defines the data classes and elements that FHIR APIs are expected to support, and has been updated through an annual public process.","appliesTo":["Certified EHR technology (CEHRT) data expectations","Payer and provider FHIR APIs"],"keyRequirements":[],"status":null,"caveats":["Which USCDI version a certified product must support is set by the certification program's rules and timelines, not by the newest release alone."],"aliases":["United States Core Data for Interoperability","USCDI"],"url":"https://hospitalroom.org/standards/uscdi","sources":[{"label":"USCDI — ONC official page","url":"https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi","note":"publisher"},{"label":"USCDI v7 (July 2026, PDF)","url":"https://isp.healthit.gov/sites/default/files/2026-07/USCDI-Version-7-July-2026.pdf","note":"PDF"},{"label":"All USCDI versions","url":"https://isp.healthit.gov/all-uscdi-versions","note":"publisher"}],"relatedStandards":["hl7-fhir"],"relatedFrameworks":[]},{"slug":"news2","short":"NEWS2","fullName":"National Early Warning Score 2","publisher":"Royal College of Physicians (UK)","publisherUrl":null,"latest":"2017","domain":"Clinical scoring","scope":"NEWS2 is a standardized aggregate score for detecting clinical deterioration in adult patients on the general ward. It is calculated from six physiological parameters plus supplemental oxygen and consciousness, and is the most widely cited early-warning score in continuous-monitoring guides.","appliesTo":["General ward adult inpatients","Escalation ladders for rapid-response teams"],"keyRequirements":[{"label":"Parameters","detail":"Respiratory rate, SpO2, supplemental O2, temperature, systolic BP, heart rate, level of consciousness."},{"label":"Escalation thresholds","detail":"Aggregate ≥ 5 or any single parameter scoring 3 triggers urgent review."}],"status":null,"caveats":[],"aliases":["National Early Warning Score 2","NEWS2"],"url":"https://hospitalroom.org/standards/news2","sources":[{"label":"NEWS2 — Royal College of Physicians","url":"https://www.rcp.ac.uk/improving-care/national-early-warning-score-news-2/","note":"publisher"}],"relatedStandards":[],"relatedFrameworks":[]},{"slug":"hipaa","short":"HIPAA","fullName":"Health Insurance Portability and Accountability Act — Privacy and Security Rules","publisher":"US Department of Health and Human Services (HHS/OCR)","publisherUrl":null,"latest":"45 CFR Parts 160 and 164","editionChecked":"2026-10-26","domain":"Privacy & security","scope":"HIPAA's Privacy Rule (Subpart E) governs the use and disclosure of protected health information, and its Security Rule (Subpart C) sets safeguards for electronic PHI. Together they define what can be recorded in the room, who may access it, and how it must be protected.","appliesTo":["Audio, video, and image capture in patient care areas","Access controls on EHR, monitor, and camera feeds","Business Associate Agreements with technology vendors"],"keyRequirements":[],"status":"US federal regulation. Enforced by HHS Office for Civil Rights (OCR).","caveats":["HHS published a proposed update to the Security Rule in January 2025. As of this check it remains a proposed rule; the current Security Rule continues to apply. Check the Federal Register for final action."],"aliases":["HIPAA Privacy Rule","HIPAA Security Rule","HIPAA","45 CFR Part 164"],"url":"https://hospitalroom.org/standards/hipaa","sources":[{"label":"HIPAA Privacy Rule (HHS)","url":"https://www.hhs.gov/hipaa/for-professionals/privacy/index.html","note":"regulator"},{"label":"HIPAA Security Rule (HHS)","url":"https://www.hhs.gov/hipaa/for-professionals/security/index.html","note":"regulator"},{"label":"45 CFR Part 164 (eCFR)","url":"https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164","note":"federal regulation"}],"relatedStandards":["nist-800-66","iso-27701"],"relatedFrameworks":[{"slug":"ai-sensing-readiness","url":"https://hospitalroom.org/frameworks/ai-sensing-readiness"}]},{"slug":"nist-800-66","short":"NIST SP 800-66","fullName":"NIST Special Publication 800-66 Rev. 2 — Implementing the HIPAA Security Rule","publisher":"National Institute of Standards and Technology","publisherUrl":null,"latest":"Revision 2 (2024)","domain":"Privacy & security","scope":"NIST's implementation guidance for the HIPAA Security Rule. It maps the Security Rule's administrative, physical, and technical safeguards to the NIST Cybersecurity Framework and provides concrete controls for covered entities.","appliesTo":["Risk analysis and management programs","Access control, audit, integrity, and transmission security"],"keyRequirements":[],"status":null,"caveats":[],"aliases":["NIST SP 800-66r2","NIST SP 800-66","SP 800-66"],"url":"https://hospitalroom.org/standards/nist-800-66","sources":[{"label":"NIST SP 800-66 Rev. 2 (PDF)","url":"https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-66r2.pdf","note":"publisher"},{"label":"NIST SP 800-66 landing page","url":"https://csrc.nist.gov/pubs/sp/800/66/r2/final","note":"NIST CSRC"}],"relatedStandards":["hipaa"],"relatedFrameworks":[]},{"slug":"iso-27701","short":"ISO/IEC 27701","fullName":"ISO/IEC 27701 — Privacy Information Management System","publisher":"ISO / IEC","publisherUrl":null,"latest":"2025 (Edition 2, 2025-10; replaces 2019)","editionChecked":"2026-10-26","domain":"Privacy & security","scope":"A privacy information management system (PIMS) standard with requirements and guidance for organizations acting as PII controllers or processors. The 2019 edition was an extension to ISO/IEC 27001; the 2025 edition is a standalone management-system standard that can still be integrated with 27001. Referenced by hospitals building privacy-management programs beyond HIPAA's baseline.","appliesTo":["Privacy governance and controller/processor roles","Third-party data-processing arrangements"],"keyRequirements":[],"status":null,"caveats":[],"aliases":["ISO/IEC 27701:2025","ISO/IEC 27701:2019","ISO/IEC 27701","ISO 27701"],"url":"https://hospitalroom.org/standards/iso-27701","sources":[{"label":"ISO/IEC 27701:2025","url":"https://www.iso.org/standard/27701","note":"publisher"},{"label":"ISO/IEC 27701:2019 (withdrawn)","url":"https://www.iso.org/standard/71670.html","note":"publisher"}],"relatedStandards":["hipaa"],"relatedFrameworks":[]},{"slug":"ies-rp-29","short":"IES RP-29","fullName":"ANSI/IES RP-29 — Recommended Practice: Lighting Hospital and Healthcare Facilities","publisher":"Illuminating Engineering Society","publisherUrl":null,"latest":"ANSI/IES RP-29-25 (supersedes RP-29-22)","editionChecked":"2026-10-26","domain":"Lighting","scope":"RP-29 is the applications standard for lighting design in hospitals, including inpatient rooms. It defines target illuminance for exam, ambient, and night settings, plus glare, color rendering, and circadian considerations.","appliesTo":["Exam light illuminance at the bed","Ambient and night-mode lighting","Color rendering (CRI) and correlated color temperature"],"keyRequirements":[{"label":"Exam lighting","detail":"Higher task illuminance at the patient for examination, separately controlled from ambient light."},{"label":"Ambient lighting","detail":"General patient-room lighting with controls for patient and staff."},{"label":"Night lighting","detail":"Low-level lighting for safe movement at night with minimal sleep disruption."}],"status":null,"caveats":["RP-29 is a recommended practice, not a code; target values are in the paid official text."],"aliases":["IES RP-29","RP-29"],"url":"https://hospitalroom.org/standards/ies-rp-29","sources":[{"label":"IES RP-29 — publisher store","url":"https://store.ies.org/product/recommended-practice-lighting-hospital-and-healthcare-facilities/","note":"publisher"},{"label":"ANSI/IES RP-29-25 overview (ANSI blog)","url":"https://blog.ansi.org/ansi/lighting-healthcare-facilities-ansi-ies-rp-29-25/","note":"ANSI"}],"relatedStandards":["fgi-guidelines"],"relatedFrameworks":[]},{"slug":"cdc-environmental-infection","short":"CDC Environmental Infection Control","fullName":"CDC Guidelines for Environmental Infection Control in Health-Care Facilities","publisher":"US Centers for Disease Control and Prevention","publisherUrl":null,"latest":"2003, with updates","domain":"Infection control","scope":"The CDC's authoritative guidance on environmental controls for infection prevention in healthcare buildings. It defines ventilation, filtration, water, and construction/renovation practices to reduce healthcare-associated infections, and is the basis for AIIR requirements in the US.","appliesTo":["Airborne infection isolation rooms (AIIRs)","Protective environment rooms for immunocompromised patients","Renovation and construction infection-control risk assessment"],"keyRequirements":[],"status":null,"caveats":[],"aliases":["CDC Guidelines for Environmental Infection Control in Health-Care Facilities","CDC Environmental Infection Control","CDC guidelines"],"url":"https://hospitalroom.org/standards/cdc-environmental-infection","sources":[{"label":"CDC Guidelines for Environmental Infection Control (2003)","url":"https://www.cdc.gov/infection-control/hcp/environmental-control/index.html","note":"publisher"},{"label":"Full guideline (PDF)","url":"https://www.cdc.gov/infection-control/media/pdfs/Guideline-Environmental-H.pdf","note":"CDC PDF"}],"relatedStandards":["ashrae-170"],"relatedFrameworks":[]},{"slug":"who-noise","short":"WHO Noise Guidelines","fullName":"WHO Guidelines for Community Noise (hospital wards)","publisher":"World Health Organization","publisherUrl":null,"latest":"1999 (guidelines for community noise)","editionChecked":"2026-10-26","domain":"Design","scope":"WHO's community-noise guidelines recommend sound-level thresholds for hospital patient rooms, widely cited in acoustic-design work. Actual hospital noise routinely exceeds these levels; the guidelines set the target, not the norm.","appliesTo":["Patient room acoustic design","Alarm sound-level calibration"],"keyRequirements":[{"label":"Ward rooms, night","detail":"30 dB LAeq indoors (8-hour), with individual sound events not exceeding 40 dB LAmax (fast)."},{"label":"Ward rooms, day and evening","detail":"30 dB LAeq indoors (16-hour)."},{"label":"Treatment and observation rooms","detail":"WHO advises the equivalent level should not exceed 35 dB LAeq in most rooms where patients are treated or observed."}],"status":null,"caveats":["Values are from the 1999 Guidelines for Community Noise, section 4.3.3 and Table 4.1. WHO's 2018 Environmental Noise Guidelines for the European Region address environmental noise sources and do not replace these indoor hospital values."],"aliases":["WHO Guidelines for Community Noise","WHO noise guidelines","WHO noise"],"url":"https://hospitalroom.org/standards/who-noise","sources":[{"label":"WHO Guidelines for Community Noise (1999)","url":"https://www.who.int/publications/i/item/a68672","note":"publisher"}],"relatedStandards":[],"relatedFrameworks":[]},{"slug":"nfpa-99","short":"NFPA 99","fullName":"NFPA 99 — Health Care Facilities Code","publisher":"National Fire Protection Association (NFPA)","publisherUrl":"https://www.nfpa.org","latest":"2027 edition (current per NFPA)","domain":"Facility safety","scope":"NFPA 99 establishes criteria for levels of health care services or systems based on risk to patients, staff, or visitors, to minimize the hazards of fire, explosion, and electricity. Instead of keying requirements to the type of building, it applies them according to a documented risk assessment of what happens if a system fails. In the patient room it is the code behind medical gas and vacuum outlets, electrical systems and power continuity, electrical and gas equipment, and — in its information technology and communications chapter — nurse call.","appliesTo":["Risk categories (Category 1–4) assigned to systems and spaces through the facility's documented risk assessment","Medical gas and vacuum systems serving the headwall","Electrical systems and power continuity for patient care spaces","Electrical equipment and gas equipment used in patient care areas","Nurse call and other information technology and communications systems (Chapter 7)"],"keyRequirements":[{"label":"Category 1","detail":"Failure of the system or equipment is likely to cause major injury or death."},{"label":"Category 2","detail":"Failure is likely to cause minor injury."},{"label":"Category 3","detail":"Failure is not likely to cause injury (the 2012 edition adds: but can cause patient discomfort)."},{"label":"Category 4","detail":"Failure would have no impact on patient care."},{"label":"Risk assessment","detail":"The facility defines, implements, and documents its risk assessment methodology. CMS does not prescribe a particular method but confirms on survey that one is in use."},{"label":"Gas and vacuum systems","detail":"In the 2012 edition, Chapter 5 covers performance, maintenance, installation, and testing of nonflammable medical gas systems below 300 psi gauge, vacuum systems, waste anesthetic gas disposal (WAGD), and connected manufactured assemblies. It does not mandate installing these systems; it governs them where installed or required."},{"label":"Electrical systems","detail":"In the 2012 edition, Chapter 6 covers performance, maintenance, and testing of facility electrical systems, addressing shock, power continuity, fire, and explosion hazards."}],"status":"US: the 2012 edition is incorporated by reference in CMS Conditions of Participation (42 CFR 482.41), with Chapters 7, 8, 12, and 13 excluded for hospitals. State and local adoption varies.","caveats":["NFPA revises the code on a regular cycle, and chapter numbers and wording can change between editions. Chapter references here follow the 2012 edition that CMS incorporates by reference.","CMS's adoption excludes Chapter 7 (Information Technology and Communications Systems), Chapter 8 (Plumbing), Chapter 12 (Emergency Management), and Chapter 13 (Security Management) for hospitals. Whether a later edition, or an excluded chapter such as the nurse-call provisions, applies to a given building depends on state and local adoption and the authority having jurisdiction.","Risk categories describe the consequence of a system failing; they are assigned by the facility's own risk assessment, not by room type alone.","This is a summary for orientation. Consult the official NFPA text for definitive requirements."],"aliases":["NFPA 99 Health Care Facilities Code","Health Care Facilities Code","NFPA 99"],"url":"https://hospitalroom.org/standards/nfpa-99","sources":[{"label":"NFPA 99, Health Care Facilities Code — document information","url":"https://www.nfpa.org/codes-and-standards/nfpa-99-standard-development/99","note":"publisher"},{"label":"42 CFR 482.41 — Condition of participation: Physical environment (eCFR)","url":"https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-C/section-482.41","note":"US regulation"},{"label":"CMS-3277-F final rule, Fire Safety Requirements for Certain Health Care Facilities (Federal Register, May 4, 2016)","url":"https://www.federalregister.gov/documents/2016/05/04/2016-10043/medicare-and-medicaid-programs-fire-safety-requirements-for-certain-health-care-facilities","note":"chapter summaries and risk categories"},{"label":"CMS memo S&C 16-29-LSC — adoption of the 2012 NFPA 101 and NFPA 99","url":"https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-16-29","note":"regulator"},{"label":"How to apply NFPA 99 to medical gas, telecommunication systems (Consulting-Specifying Engineer)","url":"https://www.csemag.com/how-to-apply-nfpa-99-to-medical-gas-telecommunication-systems/","note":"secondary source; nurse-call summary"}],"relatedStandards":["fgi-guidelines","ashrae-170","ihe-acm"],"relatedFrameworks":[{"slug":"nurse-call-routing-readiness","url":"https://hospitalroom.org/frameworks/nurse-call-routing-readiness"}]},{"slug":"ihe-acm","short":"IHE ACM","fullName":"IHE Devices — Alert Communication Management (ACM) Integration Profile","publisher":"IHE International — Devices (DEV) domain, formed as Patient Care Device (PCD)","publisherUrl":"https://www.ihe.net/ihe_domains/devices/","latest":"Devices Technical Framework Rev. 10.0 (Final Text, Nov 2024)","domain":"Interoperability","scope":"ACM is an IHE integration profile for getting an alert — a physiological or technical alarm, or an advisory such as a workflow event — from a patient care device or system to a person's communication device, and reporting back what happened. An Alert Reporter sends the alert to an Alert Manager over HL7 v2; the Alert Manager decides who should receive it and on which device, and hands it to an Alert Communicator over WCTP; delivery status, read receipts, and operator responses flow back. The profile was previously named Alarm Communication Management and was renamed to cover advisories as well as alarms.","appliesTo":["Routing bedside monitor, infusion pump, and other device alerts to clinicians' phones, pagers, and other endpoint devices","Nurse-call systems acting as an alert source — the profile's own location-sourced use case is a patient pulling a nurse call","Destination selection from configured nurse-to-patient assignments and nurse-to-device mappings","Closed-loop status: delivery confirmation, read receipt, and accept/reject returned to the alert source"],"keyRequirements":[{"label":"Actors","detail":"Alert Reporter (AR), Alert Manager (AM), and Alert Communicator (AC), plus an Alert Consumer (ACON) that receives alerts without disseminating them."},{"label":"Report Alert [PCD-04]","detail":"AR to AM over HL7 v2 (ORU^R40): a new alert, an update, or the end of an alert. One alert per transaction."},{"label":"Report Alert Status [PCD-05]","detail":"Optional, AM to AR over HL7 v2: recipients, delivery confirmation, read receipt, and operator response. An AR that receives it must at minimum log it."},{"label":"Disseminate Alert [PCD-06]","detail":"AM to AC over WCTP, for delivery to endpoint communication devices."},{"label":"Report Dissemination Alert Status [PCD-07]","detail":"AC to AM over WCTP: success or failure of delivery to the endpoint and the operator's response."},{"label":"Alert semantics","detail":"Alert type, priority, inactivation state, and escalation or de-escalation of priority are based on IEC 60601-1-8 definitions."}],"status":"Final Text in the IHE Devices Technical Framework. Voluntary interoperability profile; implementation is a vendor claim.","caveats":["The profile states that defining escalation actions when a notification is not responded to is outside its scope, as is consolidation of alerts. Escalation rules and timers remain local configuration.","IHE frames ACM as a secondary means of notifying the appropriate person — a layer on top of local annunciation at the device or nurse-call system, not a replacement for it.","Support for a profile, and for its options, varies by implementation. Ask for IHE integration statements and testing evidence rather than relying on a feature list.","Documents and transaction numbers still carry the PCD prefix (for example PCD-04) after the domain was renamed Devices."],"aliases":["IHE PCD Alert Communication Management","IHE PCD Alarm Communication Management","IHE Alert Communication Management","Alert Communication Management","Alarm Communication Management","IHE PCD ACM","IHE ACM"],"url":"https://hospitalroom.org/standards/ihe-acm","sources":[{"label":"IHE Wiki — Alert Communication Management overview","url":"https://wiki.ihe.net/index.php/PCD_Profile_Alarm_Communication_Management_Overview","note":"IHE"},{"label":"IHE Devices domain — profile list","url":"https://www.ihe.net/ihe_domains/devices/","note":"publisher"},{"label":"IHE Devices Technical Framework, Vol. 1 — Profiles (ACM, section 6)","url":"https://www.ihe.net/uploadedFiles/Documents/DEV/IHE_DEV_TF_Vol1.pdf","note":"official text (PDF)"},{"label":"IHE Devices Technical Framework, Vol. 2 — Transactions","url":"https://www.ihe.net/uploadedFiles/Documents/DEV/IHE_DEV_TF_Vol2.pdf","note":"official text (PDF)"}],"relatedStandards":["iec-60601-1-8","hl7-v2","ihe-dec","nfpa-99"],"relatedFrameworks":[{"slug":"alarm-path-readiness","url":"https://hospitalroom.org/frameworks/alarm-path-readiness"},{"slug":"nurse-call-routing-readiness","url":"https://hospitalroom.org/frameworks/nurse-call-routing-readiness"}]},{"slug":"ihe-dec","short":"IHE DEC","fullName":"IHE Devices — Device Enterprise Communication (DEC) Integration Profile","publisher":"IHE International — Devices (DEV) domain, formed as Patient Care Device (PCD)","publisherUrl":"https://www.ihe.net/ihe_domains/devices/","latest":"Devices Technical Framework Rev. 10.0 (Final Text, Nov 2024)","domain":"Interoperability","scope":"DEC is the IHE profile for publishing point-of-care device data — from vital signs monitors, infusion pumps, ventilators, anesthesia systems, and similar devices — to enterprise applications such as clinical information systems and EHRs. A Device Observation Reporter, typically a gateway, device, or clinical information system, maps proprietary device data into a single syntactic and semantic representation, time-stamps it with consistent enterprise time, and sends it to a Device Observation Consumer as an HL7 v2 message. The ACM alert profile extends DEC.","appliesTo":["Charting validated vital signs and device observations from the bedside into the EHR","Device gateways and integration middleware between bedside devices and enterprise systems","Binding patient identity to device data — the profile recommends IHE patient demographics transactions (ITI-21, ITI-30, ITI-31) and treats bar code or RFID as valid alternatives"],"keyRequirements":[{"label":"Actors","detail":"Device Observation Reporter (DOR) and Device Observation Consumer (DOC)."},{"label":"Communicate PCD Data [PCD-01]","detail":"HL7 v2 ORU^R01, an unsolicited update initiated by the DOR. MLLP transport by default, with a Web Services transport option."},{"label":"Consistent semantics and time","detail":"Device data is mapped to one syntactic and semantic representation and time-stamped with a consistent enterprise time."},{"label":"Subscribe to Patient Data","detail":"An optional publish/subscribe extension (DEC-SPD) lets consuming applications negotiate which device data they receive."}],"status":"Final Text in the IHE Devices Technical Framework. Voluntary interoperability profile; implementation is a vendor claim.","caveats":["The profile assumes implementation within a single enterprise on a secure network and does not itself address privacy, security, and confidentiality of cross-enterprise exchange.","DEC does not address open- or closed-loop control of devices, and real-time data such as alarms and waveforms is outside DEC itself; alerts are carried by the ACM profile.","Correct device–patient association remains a separate, safety-critical problem; IHE calls patient identification perhaps the most essential infrastructural component of device data exchange.","Support for a profile, and for its options, varies by implementation. Ask for IHE integration statements and testing evidence rather than relying on a feature list."],"aliases":["IHE PCD Device Enterprise Communication","Device Enterprise Communication","IHE PCD DEC","IHE DEC"],"url":"https://hospitalroom.org/standards/ihe-dec","sources":[{"label":"IHE Wiki — Device Enterprise Communication","url":"https://wiki.ihe.net/index.php/Device_Enterprise_Communication","note":"IHE"},{"label":"IHE Devices domain — profile list","url":"https://www.ihe.net/ihe_domains/devices/","note":"publisher"},{"label":"IHE Devices Technical Framework, Vol. 1 — Profiles (DEC, section 3)","url":"https://www.ihe.net/uploadedFiles/Documents/DEV/IHE_DEV_TF_Vol1.pdf","note":"official text (PDF)"},{"label":"IHE Devices Technical Framework, Vol. 2 — Transactions (PCD-01)","url":"https://www.ihe.net/uploadedFiles/Documents/DEV/IHE_DEV_TF_Vol2.pdf","note":"official text (PDF)"}],"relatedStandards":["ihe-acm","hl7-v2","iso-ieee-11073","hl7-fhir"],"relatedFrameworks":[{"slug":"device-integration-readiness","url":"https://hospitalroom.org/frameworks/device-integration-readiness"}]},{"slug":"iec-80001-1","short":"IEC 80001-1","fullName":"IEC 80001-1:2021 — Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software","publisher":"International Electrotechnical Commission (IEC), published jointly with ISO (ISO/TC 215)","publisherUrl":"https://webstore.iec.ch/en/publication/34263","latest":"Edition 2.0 (2021-09)","editionChecked":"2026-10-26","domain":"Devices","scope":"IEC 80001-1 is written for the organization that connects things, not the manufacturer that builds them. It sets general requirements for a healthcare delivery organization to apply risk management before, during, and after a health IT system — including connected medical devices and health software — is connected to its health IT infrastructure, addressing three key properties: safety, effectiveness, and security. The 2021 second edition replaced the 2010 first edition, restructured the standard to align with ISO 31000, and placed the requirements on the organization.","appliesTo":["Connecting bedside monitors, pumps, and other devices to the hospital network, middleware, or EHR","Changes to an already-connected system: network upgrades, software updates, new integrations, decommissioning","Shared responsibilities between the hospital, device manufacturers, and IT service providers","Wired, wireless, and cloud-hosted infrastructure that carries clinical traffic alongside non-clinical traffic"],"keyRequirements":[{"label":"Who it binds","detail":"Requirements apply to the organization responsible for the health IT infrastructure, not to device manufacturers' product design."},{"label":"Three key properties","detail":"Risk management addresses safety, effectiveness, and security together rather than treating security as a separate track."},{"label":"Lifecycle coverage","detail":"Risk management applies before, during, and after connection — the 'implementation and clinical use' phase of the ISO 81001-1 health software lifecycle."},{"label":"Alignment with ISO 31000","detail":"The 2021 edition's structure follows ISO 31000 so an existing enterprise risk process can be used or adapted."},{"label":"Stakeholder engagement","detail":"Appropriate stakeholders (clinical, biomedical/clinical engineering, IT, and suppliers) are engaged in the risk management process."}],"status":"Voluntary international standard. IEC lists a stability date of 2028; ISO lists it as 'to be revised'. Adoption is an organizational decision; it is not a product certification.","caveats":["This is an orientation summary of the publicly available abstract and preview. The requirements themselves are in the paid official text.","The US FDA recognized-standards database lists the 2010 first edition (recognition 13-38) and several IEC TR 80001-2-x guidance documents, including TR 80001-2-5 on distributed alarm systems. At the time of checking, the 2021 edition did not appear in that search. FDA recognition concerns premarket submissions by manufacturers, while 80001-1 is aimed at the organizations that deploy devices.","Conformance is not a label a device can carry. A manufacturer can supply information that supports a hospital's 80001-1 process, but cannot make the hospital conformant."],"aliases":["IEC 80001-1:2021","IEC 80001-1","80001-1"],"url":"https://hospitalroom.org/standards/iec-80001-1","sources":[{"label":"IEC 80001-1:2021 — IEC Webstore","url":"https://webstore.iec.ch/en/publication/34263","note":"publisher"},{"label":"IEC 80001-1:2021 — ISO listing","url":"https://www.iso.org/standard/72026.html","note":"ISO"},{"label":"FDA Recognized Consensus Standards database (search 80001)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=80001-1","note":"regulator"}],"relatedStandards":["iec-60601-1","iec-60601-1-8","ihe-dec","iso-ieee-11073","hipaa","nist-800-66"],"relatedFrameworks":[{"slug":"device-integration-readiness","url":"https://hospitalroom.org/frameworks/device-integration-readiness"},{"slug":"ai-sensing-readiness","url":"https://hospitalroom.org/frameworks/ai-sensing-readiness"}]},{"slug":"ul-1069","short":"UL 1069","fullName":"ANSI/UL 1069 — Standard for Hospital Signaling and Nurse Call Equipment","publisher":"UL Standards & Engagement","publisherUrl":"https://www.shopulstandards.com/ProductDetail.aspx?productId=UL1069","latest":"8th edition (February 8, 2024; ANSI approved the same date)","editionChecked":"2026-10-26","domain":"Facility safety","scope":"UL 1069 is the US safety standard for the individual units and equipment that make up a fundamental hospital signaling nurse call system (NCS). Its scope defines a fundamental NCS as providing audible and visual communication between patients and staff, conforming to the minimum requirements of the Health Care Facilities Code (NFPA 99) and the National Electrical Code (NFPA 70). It is the reason the core call path — pull, annunciate, dome light, reset — is evaluated as a safety function rather than a convenience feature.","appliesTo":["Patient and staff call stations, pillow speakers, and pull cords that initiate calls","Primary call notification (master) stations, corridor dome lights, and zone lights","Wireless interfaces used for fundamental or supplementary nurse-call operation","Accessory equipment interfaced to the NCS that initiates routine calls but not emergency or code calls"],"keyRequirements":[{"label":"Minimal fundamental operations","detail":"Call initiation from a fixed or portable station; audible and visual annunciation at a primary notification station; a visual call-placed indicator at the initiating station; corridor dome light annunciation; zone annunciation; and call reset/cancellation."},{"label":"Wireless","detail":"A fundamental NCS may use a wireless interface for fundamental operations or for supplementary operation such as notification at a redundant portable nurse station."},{"label":"Installation context","detail":"Units are intended for patient care, staff, and support areas, installed in accordance with NFPA 70 and NFPA 99."},{"label":"2024 edition changes","detail":"Added requirements for Class 2 supply equipment and trimmed the glossary, with editorial renumbering."},{"label":"Exclusions","detail":"Does not cover medical and dental equipment, office intercoms, equipment in hyperbaric oxygenation areas, and other equipment with its own requirements."}],"status":"ANSI-approved US safety standard used for product listing of nurse-call equipment. It evaluates equipment; it does not set staffing, response-time, or routing policy.","caveats":["UL lists two open CSDS proposals against this standard (dated March 13, 2026 and September 18, 2026). Proposals are not published requirements; check the publisher page for any revision before relying on edition details.","Listing to UL 1069 covers the fundamental call path. Smartphone delivery, middleware routing, and escalation rules layered on top are generally outside its scope — see the IHE ACM profile and local policy.","This summary is drawn from the publicly visible scope and summary of topics. Detailed test requirements are in the paid official text."],"aliases":["ANSI/UL 1069","UL 1069"],"url":"https://hospitalroom.org/standards/ul-1069","sources":[{"label":"UL 1069 — UL Standards & Engagement","url":"https://www.shopulstandards.com/ProductDetail.aspx?productId=UL1069","note":"publisher"},{"label":"NFPA 99 — Health Care Facilities Code","url":"https://www.nfpa.org/codes-and-standards/nfpa-99-standard-development/99","note":"referenced code"}],"relatedStandards":["nfpa-99","ihe-acm","fgi-guidelines"],"relatedFrameworks":[{"slug":"nurse-call-routing-readiness","url":"https://hospitalroom.org/frameworks/nurse-call-routing-readiness"}]}]}