M/BC/CEN/88/9 - PPE: Foot and leg protection
Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection
This mandate concerns the revision of European standards related to personal protective equipment (PPE) specifically for foot and leg protection. It tasks CEN/TC 136 with updating existing EN and ENV standards to ensure their continued relevance and effectiveness in safeguarding users. The revision aims to align the standards with current safety requirements, technological advancements, and regulatory frameworks, enhancing the protection offered by PPE for foot and leg injuries in various work environments.
Purpose
This mandate concerns the standardization of Personal Protective Equipment (PPE) specifically for foot and leg protection. It aims to revise existing European Standards (ENs) and European Pre-Standard (ENVs) to ensure that the protective equipment meets updated safety, health, and performance requirements.
Standardisation request
The request is directed to CEN Technical Committee 136 (CEN/TC 136), which is responsible for the development and maintenance of standards related to foot and leg protection. The mandate requires the revision of current standards to reflect technological advancements and regulatory needs.
Expected deliverables
- Revised European Standards (ENs) and European Pre-Standards (ENVs) relating to PPE for foot and leg protection.
- Updated documentation that ensures compliance with relevant European safety regulations.
- Harmonized standards facilitating the manufacturing, testing, and certification of foot and leg protective equipment within the EU market.
Context
This mandate follows resolution reference CEN/TC 136 196/2003 and is part of the broader EU framework on PPE standardisation. The update is necessary to maintain high levels of user protection, incorporate new materials and technologies, and align with EU legislation on occupational safety. Revising the standards ensures the continued free movement of compliant PPE products within the single market.
This mandate covers the standardisation of Personal Protective Equipment (PPE) specifically focused on foot and leg protection. It involves revising existing European Standards (ENs/ENVs) related to protective footwear and leg wear designed to ensure safety in various occupational environments.
General Information
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
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
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
- Amendment17 pagesEnglish languagee-Library read for1 day
- Corrigendum2 pagesEnglish, French and German 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 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 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
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
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 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 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 344-1:1992 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
- Amendment17 pagesEnglish languagee-Library read for1 day
- Amendment4 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
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.