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Standards [CURRENT]

DIN EN ISO 23500-4

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019); German version EN ISO 23500-4:2019
Edition 2019-11

Standards [CURRENT]

DIN EN ISO 13408-4

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011
Edition 2011-09

Standards [CURRENT]

DIN EN ISO 23500-5

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019); German version EN ISO 23500-5:2019
Edition 2019-11

Draft standard

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023
Edition 2023-02

Standards [CURRENT]

DIN EN ISO 15883-2

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006); German version EN ISO 15883-2:2009
Edition 2009-09

Standards [CURRENT]

DIN EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 23500-3

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019); German version EN ISO 23500-3:2019
Edition 2019-11

Standards [CURRENT]

DIN EN ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017
Edition 2017-07

Draft standard

DIN EN ISO 23500-5

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022); German and English version prEN ISO 23500-5:2022
Edition 2022-12

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