BS EN ISO 17665-1:2006 - Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices – BSI British Standards

BS EN ISO 17665-1:2006

Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

Status : Current, Work in hand   Published : September 2006
Conformity to regulation : Designated



What is BS EN ISO/IEC 17665:2006?

BS EN ISO 17665 sets out the requirements to ensure best practice steam sterilisation of medical equipment. By following this standard’s guidelines, the steam sterilisation process is more likely to produce sterile medical instruments on treatment and improve overall quality control. Although BS EN ISO 17665 is limited to medical equipment, its requirements and guidelines can also be applied to other health care products. It’s important to remember that an accurately controlled sterilisation process is not the only factor that ensures a product is sterile.

How does it work?

To improve the performance of steam sterilisation processes, BS EN ISO 17665 looks at the microbiological status of incoming raw materials. It demonstrates the verification and route control of any cleaning and disinfection procedures used on the product. BS EN ISO 17665 also defines the control of the environment where the product is manufactured, assembled and packaged, as well the management of the personnel’s hygiene.

Who should buy it?

  • Hospitals
  • Health care centres
  • Personnel dealing with steam sterilisation
  • Manufacturers of steam sterilisers
    Suppliers of medical equipment
  • Regulatory bodies
  • Inspectors
  • Health and safety officers

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Standard NumberBS EN ISO 17665-1:2006
TitleSterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
StatusCurrent, Work in hand
Publication Date29 September 2006
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 11138-3:2017, ISO 11737-2:2019, ISO 11138-1:2017, BS EN ISO 11737-2:2020, ISO 11737-1:2018, ISO 17664:2017, ISO 11607-1, ISO 13485:2003, ISO 11607-2, ISO 11140-1, ISO 11140-5, ISO 11140-4, ISO 10012, ISO 11140-3
Informative References(Provided for Information)EN 868-4:1999, EN 12442-3:2000, ISO 9004:2000, EN 868-8:1999, BS EN ISO 18472:2018, EN 868-5:1999, EN 868-3:1999, ISO 14937:2000, ISO 14040, EN 13060, IEC 61010-2-040, ISO 10993-1, ISO/TS 11139, ISO 22442-1, ISO 22442-3, 93/42/EEC, 90/385/EEC, ISO 14971, ISO 9000:2005, ISO 10993-17, VIM:1993, ISO 14161:2000, ISO 14001, ISO 15883-2, ANSI/AAMI ST67:2003, ISO 15882:2003, EN 556-1, ISO 22442-2, EN 285, 98/79/EEC, ISO 15883-4:2018, EN 868-10:2000, ISO 9001:2000, EN 12442-2:2000, ISO 15883-1, BS EN ISO 15883-4:2018, EN 12442-1:2000, ISO 18472:2018, EN 868-9:2000, EN 868-2:1999, EN 868-1:1997, ISO 9000-3:1991
ReplacesBS EN 554:1994
International RelationshipsEN ISO 17665-1:2006,ISO 17665-1:2006
Draft Superseded By04/30048205 DC
DescriptorsPersonnel, Steam sterilizers, Medical instruments, Quality control, Verification, Installation, Maintenance, Sterilization (hygiene), Medical equipment, Acceptance (approval), Quality assurance, Steam, Performance, Sterilizers
Title in FrenchSterilisation des produits de sante. Chaleur humide. Exigences pour le developpement, la validation et le controle de routine d'un procede de sterlisation des dispositifs medicaux
Title in GermanSterilisation von Produkten fuer die Gesundheitsfuersorge. Feuchte Hitze . Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fuer Medizinprodukte
ISBN0 580 48982 5
File Size730 KB

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