M/BC/CEN/88/9 - PPE: Foot and leg protection

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.

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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

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.

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.

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.

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.

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

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.

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

This European Standard specifies, by reference to EN 344:1992, basic and additional (optional) requirements for protective footwear for professional use.

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

This European Standard specifies, by reference to EN 344:1992, basic and additional (optional) requirements for protective footwear for professional use.

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

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.