Quality management - Customer satisfaction - Guidelines for codes of conduct for organizations (ISO 10001:2007); Text in German, English and French— 39 стр.
Instruments for use in association with non-active surgical implants - General requirements (ISO/DIS 16061:2020); German and English version prEN ISO 16061:2020
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Health informatics - Clinical analyser interfaces to laboratory information systems - Use of profiles (ISO 18812:2003); German version EN ISO 18812:2003, text in English— 59 стр.
Health informatics - Privilege management and access control - Part 1: Overview and policy management (ISO 22600-1:2014); German version EN ISO 22600-1:2014— 36 стр.
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021); German and English version EN ISO 25424:2019/prA1:2021
Information technology - Security techniques - Information security management systems - Requirements (ISO/IEC 27001:2013 including Cor 1:2014 and Cor 2:2015)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011 + Amd 1:2015 + Amd 2:2018) (consolidated version)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018); German version EN ISO 80601-2-55:2018— 79 стр.
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019
Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications - Part 1: Specification for products (ISO/DIS 12609-1:2019); German and English version prEN ISO 12609-1:2019
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use— 24 стр.
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
Information technology - Security techniques - Code of practice for information security controls (ISO/IEC 27002:2013 including Cor 1:2014 and Cor 2:2015)
Fixed firefighting systems - Gas extinguishing systems - Part 6: Physical properties and system design of gas extinguishing systems for HFC 23 extinguishant (ISO 14520-10:2019, modified)
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014— 69 стр.
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM— 14 стр.
Quality management - Customer satisfaction - Guidelines for dispute resolution external to organizations (ISO 10003:2007); Text in German, English and French— 61 стр.
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007) (english version)
Medical electrical equipment -- Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (IEC 60601-2-25:2011) (english version)
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 60601-2-26:2012) (english version)
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011) (english version)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (IEC 60601-2-34:2011) (english version)
Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis(IEC 60601-2-41:2009 + A1:2013) (english version)
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (IEC 60601-2-46:2010) (english version)
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (IEC 60601-2-47:2012) (english version)
Medical electrical equipment -- Part 2-52: Particular requirements for the basic safety and essential performance of medical beds (IEC 60601-2-52:2009 + Cor.:2010 + A1:2015) (english version)
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011) (english version)
Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010); German version EN ISO 8362-6:2011— 11 стр.
Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006); German version EN ISO 8362-7:2010— 12 стр.
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO/DIS 10079-3:2021); German and English version prEN ISO 10079-3:2021
Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015); English version EN ISO 11073-00103:2017— 89 стр.
Health informatics - Device interoperability - Part 10101: Point-of-care medical device communication - Nomenclature (ISO/IEEE 11073-10101:2020); English version EN ISO 11073-10101:2020, only on CD-ROM
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014, Corrected version 2014-05-01)
Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE 11073-10201:2020)
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012); English version EN ISO 11073-10406:2012— 78 стр.
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2017); English version EN ISO 11073-10417:2017— 74 стр.
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016); English version EN ISO 11073-10418:2014/AC:2016— 19 стр.
Aerospace series - Cables, electrical for general purpose - Operating temperatures between -55 °C and 260 °C - Part 003: Product standard; German and English version FprEN 2854-003:2019
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016); English version EN ISO 11073-10419:2016— 146 стр.
Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012); English version EN ISO 11073-10420:2012— 66 стр.
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012); English version EN ISO 11073-10421:2012— 67 стр.
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) - Technical Corrigendum 1 (ISO/IEEE 11073-10424:2016/Cor 1:2018); English version EN ISO 11073-10424:2016/AC:2018— 31 стр.
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019); English version EN ISO 11073-10425:2019
Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015); English version EN ISO 11073-10441:2017— 119 стр.
Health informatics - Personal health device communication - Part 10442: Device specialization - Strength fitness equipment (ISO/IEEE 11073-10442:2015, corrected version 2017-11-01)
Health Informatics - Personal health device communication - Part 10471: Device specialization - Independant living activity hub (ISO/IEEE 11073-10471:2010)
Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012); English version EN ISO 11073-10472:2012— 77 стр.
Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004); English version EN ISO 11073-20101:2005— 86 стр.
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016)
Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected - Amendment 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015); English version EN ISO 11073-30200:2005/A1:2015— 45 стр.
Health informatics - Point-of-care medical device communication - Part 30300: Transport profile - Infrared wireless (ISO/IEEE 11073-30300:2004); English version EN ISO 11073-30300:2005— 67 стр.
Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012); English version EN ISO 11073-30400:2012— 46 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005); German version EN ISO 11810-1:2009— 20 стр.
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007); German version EN ISO 11810-2:2009— 21 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019); German version EN ISO 14644-16:2019— 58 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
