Sterilisering

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 sep 2022
Se merSe mindre
 

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.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 okt 2022
Se merSe mindre
 

This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 8 nov 2022
Se merSe mindre
 

This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers.
NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.
This document applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
– in hospitals, in community medical facilities and in dental institutions;
– in clinics of schools, of kindergardens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE 2 This method corresponds to a phase 2, step 2 test.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 15 nov 2022
Se merSe mindre
 

This document specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water or - in the case of ready-to-use products - with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues. The scope of this document applies at least to the following: a) processing, distribution and retailing of: 1) food of animal origin: i) milk and milk products; ii) meat and meat products; iii) fish, seafood and products; iv) eggs and egg products; v) animal feeds; vi) etc. 2) food of vegetable origin: i) beverages; ii) fruits, vegetables and derivatives (including sugar distillery); iii) flour, milling and backing; iv) animal feeds; v) etc. b) institutional and domestic areas: 1) catering establishments; 2) public areas; 3) public transports; 4) schools; 5) nurseries; 6) shops; 7) sports rooms; 8) waste container (bins); 9) hotels; 10) dwellings; 11) clinically non sensitive areas of hospitals; 12) offices; 13) etc. c) other industrial areas: 1) packaging material; 2) biotechnology (yeast, proteins, enzymes...); 3) pharmaceutical; 4) cosmetics and toiletries; 5) textiles; 6) space industry, computer industry; 7) etc. Using this document, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non-active range, dilution of the product is required and, therefore, the product forms a homogeneous stable preparation in hard water. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used. NOTE 2 This method cannot be used to evaluate the activity of products against mycobacteria.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 15 nov 2022
Se merSe mindre
 

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. The standard also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.