DIN EN ISO 11607-2/A11 PDF

Published Date: 02/01/2024

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023) (includes Amendment A1:2023)

Published Date: 08/01/2022

Draft Document - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022

Published Date: 08/01/2022

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022

Published Date: 05/01/2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020

Published Date: 11/01/2017

Draft Document - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017

Published Date: 10/01/2017

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1.:2014)

Published Date: 11/01/2014

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014) (includes Amendment A1:2014)

Published Date: 04/01/2013

Draft Document - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/DAM 1:2013); German version EN ISO 11607-2:2006/prA1:2013

Published Date: 07/01/2006

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

Published Date: 03/01/2019

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

Published Date: 02/01/2024

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)

Published Date: 08/01/2007

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

Published Date: 12/01/2001

Guidelines for Quality Management System Documentation (Adopted ISO/TR 10013:2001, first edition, 2001-07-15)

Published Date: 04/02/2000

Guidelines for Managing the Economics of Quality (Adopted Technical Report ISO/TR 10014:1998, first edition, 1999-08-01)

Published Date: 04/01/2000

Guidance on Statistical Techniques for ISO 9001:1994 (Adopted Technical Report ISO/TR 10017:1999, first edition, 1999-09-01)

Published Date: 11/01/2003

Guidance on Statistical Techniques for ISO 9001:2000 (Adopted ISO/TR 10017:2003, second edition, 2003-05-15)

Published Date: 01/01/2013

Nanotechnologies - Nanomaterial risk evaulation (Adopted ISO/TR 13121:2011, first edition, 2011-05-15)

Published Date: 10/01/2014

Breathing tubes intended for use with anaesthetic apparatus and ventilators (Adopted ISO 5367:2000, fourth edition, 2000-06-01)