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BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices >
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices, 2013
- Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices
- Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices
- Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices
- Scope [Go to Page]
- Normative references
- Terms and definitions
- Quality management system elements [Go to Page]
- Sterilizing agent characterization [Go to Page]
- Process and equipment characterization [Go to Page]
- Product definition [Go to Page]
- Process definition
- Validation [Go to Page]
- Routine monitoring and control [Go to Page]
- Product release from sterilization/depyrogenation
- Maintaining process effectiveness [Go to Page]