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Standards [CURRENT]

DIN EN ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
Edition 2024-04

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 22442-2

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
Edition 2021-04

Standards [CURRENT]

DIN EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007
Edition 2008-03

Standards [CURRENT]

DIN ISO 15309

Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices (ISO 15309:2013)
Edition 2021-12

Business plan

DIN SPEC 91509

Data model for the technical documentation of medical devices
Edition 2023-12

Technical rule [CURRENT]

DIN-Fachbericht CEN/TR 15133

Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005
Edition 2005-09

Spezielle Regeln für die Akkreditierung im Bereich Medizinprodukte "Aufbereitung von Medizinprodukten"
Edition 2013-10-16

Technical rule [CURRENT]

VDI 2083 Blatt 21

Cleanroom technology - Cleanliness of medical devices in the manufacturing process
Edition 2019-10

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