M/BC/CEN/88/9 - PPE: Foot and leg protection
Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection
General Information
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/BC/CEN/88/9 is a European Standardization Mandate titled "Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection". Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection There are 24 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
- Amendment19 pagesEnglish languagee-Library read for1 day
- Amendment23 pagesEnglish languagee-Library read for1 day
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
- Standard33 pagesEnglish languagee-Library read for1 day
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
- Amendment19 pagesEnglish languagee-Library read for1 day
- Amendment23 pagesEnglish languagee-Library read for1 day
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
- Standard33 pagesEnglish languagee-Library read for1 day
This standard specifies the requirements and test methods for packaging materials and final packages (systems) that are intended to maintain sterility of the terminally sterilized medical devices to the point of use. This standard is applicable to industry, health care facilities, and whererver sterilized medical devices are packed and sterilized.
- Standard32 pagesEnglish languagee-Library read for1 day
This standard specifies the requirements and test methods for packaging materials and final packages (systems) that are intended to maintain sterility of the terminally sterilized medical devices to the point of use. This standard is applicable to industry, health care facilities, and whererver sterilized medical devices are packed and sterilized.
- Standard32 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344-1:1992 including amendment EN 344:1992/A1:1997, basic and additional (optional) requirements for occupational footwear for professional use.1) 1. Scope was modified by Amendment A1:1997
- Standard12 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Corrigendum2 pagesEnglish, French and German languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment17 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344-1:1992 including amendment EN 344:1992/A1:1997, basic and additional (optional) requirements for safety footwear for professional use.1) 1. Scope was modified by Amendment A1:1997
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344:1992, basic and additional (optional) requirements for protective footwear for professional use.
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and, where appropriate, test methods to establish conformity with these requirements for footwear intended to protect the wearer's feet and legs against foreseeable hazards in a variety of working sectors. This standard can be used only in conjunction with EN 345:1992, EN 346:1992 or EN 347:1992, which give requirements for footwear relating to specific levels of risk.
- Standard90 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344-1:1992 including amendment EN 344:1992/A1:1997, basic and additional (optional) requirements for occupational footwear for professional use.1) 1. Scope was modified by Amendment A1:1997
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344:1992, basic and additional (optional) requirements for protective footwear for professional use.
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies, by reference to EN 344-1:1992 including amendment EN 344:1992/A1:1997, basic and additional (optional) requirements for safety footwear for professional use.1) 1. Scope was modified by Amendment A1:1997
- Standard12 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment17 pagesEnglish languagee-Library read for1 day
- Corrigendum2 pagesEnglish, French and German languagee-Library read for1 day
This European Standard specifies requirements and, where appropriate, test methods to establish conformity with these requirements for footwear intended to protect the wearer's feet and legs against foreseeable hazards in a variety of working sectors. This standard can be used only in conjunction with EN 345:1992, EN 346:1992 or EN 347:1992, which give requirements for footwear relating to specific levels of risk.
- Standard90 pagesEnglish languagee-Library read for1 day





