• The list of standards included in the COVID-19 Response Package includes the following:

    Name Title Publisher
    I.S. EN ISO 80601-2-79 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018) NSAI
    I.S. EN ISO 80601-2-80 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018) NSAI
    I.S. EN 149 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking NSAI
    I.S. EN 166 PERSONAL EYE-PROTECTION - SPECIFICATIONS NSAI
    I.S. EN 167 PERSONAL EYE-PROTECTION - OPTICAL TEST METHODS NSAI
    I.S. EN 168 PERSONAL EYE-PROTECTION - NON-OPTICAL TEST METHODS NSAI
    I.S. EN 455-1 MEDICAL GLOVES FOR SINGLE USE - PART 1: REQUIREMENTS AND TESTING FOR FREEDOM FROM HOLES NSAI
    I.S. EN 455-2 MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES NSAI
    I.S. EN 455-3 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION NSAI
    I.S. EN 455-4 MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION NSAI
    I.S. EN 13795-1 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns NSAI
    I.S. EN 13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits NSAI
    I.S. EN 14126 PROTECTIVE CLOTHING - PERFORMANCE REQUIREMENTS AND TESTS METHODS FOR PROTECTIVE CLOTHING AGAINST INFECTIVE AGENTS NSAI
    I.S. EN 14605 PROTECTIVE CLOTHING AGAINST LIQUID CHEMICALS - PERFORMANCE REQUIREMENTS FOR CLOTHING WITH LIQUID-TIGHT (TYPE 3) OR SPRAY-TIGHT (TYPE 4) CONNECTIONS, INCLUDING ITEMS PROVIDING PROTECTION TO PARTS OF THE BODY ONLY (TYPES PB [3] AND PB [4]) NSAI
    I.S. EN 14683 Medical face masks - Requirements and test methods NSAI
    I.S. EN 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE NSAI
    I.S. EN 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS NSAI
    I.S. EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability NSAI
    I.S. EN 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems NSAI
    I.S. EN 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT NSAI
    I.S. EN ISO 374-5 PROTECTIVE GLOVES AGAINST DANGEROUS CHEMICALS AND MICROORGANISMS - PART 5: TERMINOLOGY AND PERFORMANCE REQUIREMENTS FOR MICRO-ORGANISMS RISKS NSAI
    I.S. EN ISO 5356-1 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015) NSAI
    I.S. EN ISO 10651-4 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS NSAI
    I.S. EN ISO 10993-1 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) NSAI
    I.S. EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) NSAI
    I.S. EN ISO 13688 PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013) NSAI
    I.S. EN ISO 17510-1 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT NSAI
    I.S. EN ISO 18082 ANAESTHETIC AND RESPIRATORY EQUIPMENT - DIMENSIONS OF NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES (ISO 18082:2014/AMD 1:2017) NSAI
    I.S. EN ISO 22301 Security and resilience - Business continuity management systems - Requirements (ISO 22301:2019) NSAI
    I.S. EN ISO 80601-2-12 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) NSAI
    I.S. EN ISO 80601-2-13 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2- 13:2011) NSAI
    I.S. ISO 31000 Risk management - Guidelines NSAI
    ISO 20395 Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR ISO
    ISO 19223 Lung ventilators and related equipment - Vocabulary and semantics ISO
    ISO 10651-3 LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS ISO
    ISO 10651-5 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS ISO
    ISO 18562-1 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS ISO
    ISO 18562-2 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 2: TESTS FOR EMISSIONS OF PARTICULATE MATTER ISO
    ISO 18562-3 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS) ISO
    ISO 18562-4 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE ISO
    ISO 22316 SECURITY AND RESILIENCE - ORGANIZATIONAL RESILIENCE - PRINCIPLES AND ATTRIBUTES ISO
    ISO 22320 Security and resilience -- Emergency management -- Guidelines for incident management ISO
    ISO 22395 Security and resilience -- Community resilience -- Guidelines for supporting vulnerable persons in an emergency ISO
    ISO 80601-2-70 MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNOEA BREATHING THERAPY EQUIPMENT ISO
    ISO 80601-2-74 MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT ISO
    ISO TS 16976-8 RESPIRATORY PROTECTIVE DEVICES - HUMAN FACTORS - PART 8: ERGONOMIC FACTORS ISO
    AAMI PB70 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES AAMI
    AAMI TIR 11 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES AAMI
    AAMI TIR68 Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces AAMI

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