SS-EN-ISO-11607-2 › Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
SS-EN-ISO-11607-2
-
2020 EDITION
-
CURRENT
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
Included in this current edition are the following subparts:
2020 EDITION - Jan. 20, 2020
FOR 2020 EDITION AMENDMENT 11 - June 21, 2022
FOR 2020 EDITION AMENDMENT 11 - June 21, 2022
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
To find similar documents by classification:
11.080.30 (Sterilized packaging)
Medical devices
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
SIS-EN-ISO-13485Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ISO/IEC-13211-1
Information technology - Programming languages - Prolog - Part 1: General core
ISO/IEC-16022
Information technology - Automatic identification and data capture techniques - Data Matrix bar code symbology specification
Designation Name
SS-EN ISO 11607-2:2020
Revision Level
2020 EDITION
Status
Current
Publication Date
Jan. 20, 2020
Language(s)
English
Page Count
24
International Equivalent
EN ISO 11607-2:2020(IDT); ISO 11607-2:2019(IDT)