Pappersteknik

Ämnesområden: Papper och papp
Kommittébeteckning: SIS/TK 157 (Massa och papper)
Källa: CEN
Svarsdatum: den 6 nov 2017
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This European Standard describes two representative methods for the determination of the extractable amount of specific primary aromatic amines (PAA) in a water extract of paper, board and pulp samples by means of HPLC with MS/MS detection which basically differ concerning the choice of the mobile and stationary phases. Deviating from this standard further methods may be applicable if it can be shown that comparable results can be achieved. A validation should be carried out by each laboratory.

It is applicable for the determination of the 22 primary aromatic amines (PAA) mentioned in the annex of Directive 2002/61/EC of 19th July 2002 amending Council Directive 76/769/EEC relating to restrictions on the market and use of certain dangerous substances and preparations (azocolourants) which are classified as carcinogenic categories 1A and 1B according to the CLP regulation and aniline.

The method described by this standard should be also applicable for the determination of further primary aromatic amines (PAA). A validation for every further analyte has to be done by the laboratory using this method.

The extractable amount of a primary aromatic amine (PAA) is expressed in mg PAA per litre water extract. This method is suitable for the determination of PAA with a working range of about 0,001 mg/l – 0,020 mg/l water extract.

Deviating from this standard further methods may be applicable if it can be shown that comparable results can be achieved. A validation should be carried out by each laboratory.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 22 nov 2017
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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 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.

This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

This part of ISO 11607 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.