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Medical & Health - Certification & Assessment

Management system services and solutions

We provide certification and assessment services and training for all of the Medical & Health processes, equipment, accessories, services and standards. Auditing and certification is undertaken using specialist assessors in this sector.

Product certification & marks

SABS Product Services offer a Qualification Scheme for the Medical & Health Industry. This scheme provides the Medical & Health components industry with an independent qualification service that enables them to demonstrate compliance through a qualification certificate.

Related certifications

ISO/TR 21730:2007

Health informatics -- Use of mobile wireless communication and computing technology in healthcare facilities -- Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices

ISO 17665-1:2006

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 11135-1:2007

Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development validation and routine control of a sterilization process for medical devices

ISO/TS 11073-92001:2007

Health informatics -- Medical waveform format -- Part 92001: Encoding rules

ISO 11073-90101:2008

Health informatics -- Point-of-care medical device communication -- Part 90101: Analytical instruments -- Point-of-care test

IEC 60601-1-11:2010

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

ISO 14937:2009

Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices

ISO 20857:2010

Sterilization of health care products -- Dry heat -- Requirements for the development validation and routine control of a sterilization process for medical devices

ISO/IEEE 11073-10101:2004

Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature

ISO/IEEE 11073-10101:2004

Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature

ISO/IEEE 11073-30300:2004

Health informatics -- Point-of-care medical device communication -- Part 30300: Transport profile -- Infrared wireless

ISO/IEEE 11073-20101:2004

Health informatics -- Point-of-care medical device communication -- Part 20101: Application profiles -- Base standard

ISO/TR 11633-1:2009

Health informatics -- Information security management for remote maintenance of medical devices and medical information systems -- Part 1: Requirements and risk analysis

ISO/IEEE 11073-10201:2004

Health informatics -- Point-of-care medical device communication -- Part 10201: Domain information model

ISO/IEEE 11073-30200:2004

Health informatics -- Point-of-care medical device communication -- Part 30200: Transport profile -- Cable connected

ISO 11137-1:2006

Sterilization of health care products -- Radiation -- Part 1: Requirements for development validation and routine control of a sterilization process for medical devices

ISO/TR 11633-2:2009

Health informatics -- Information security management for remote maintenance of medical devices and medical information systems -- Part 2: Implementation of an information security management system (ISMS)