BS EN ISO 19001:2013 free.In vitro diagnostic medical devices – Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.
This International Standard relates to ISO 181 13-1 and ISO 18113-2, which can be used in conjunction with it.
The use of reagents required for staining in biology as well as the specific examples of information supplied bythemanufacturerfortwostainingproceduresasprovidedinAnnexAarebasedonaEuropeanconsensus; they constitute the scientific justification for the requirements listed in Clause 4. This information is intended to assist manufacturers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology in complying with the required specific product data.
This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chrornogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 80000-1, Quantities and units — Part 1: General
ISO 80000-9, Quantities and units — Part 9: Physical chemistry and molecular physics
ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-2, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
4.1 General requirements
4.1.1 Chain of suppliers
When a manufacturer uses materials supplied by a producer, the manufacturer has an obligation of assuring that the producer meets the quality systems described in Iso 9001 and ISO 13485.
4.1.2 Warning and precautions
The manufacturer of reagents used for staining in biology shall provide information regarding warning and precautions in accordance with ISO 18113-1 and ISO 18113-2.
4.1.3 Format of Information supplied by the manufacturer
The format of the information supplied by the manufacturer with reagents used for staining in biology shall be in accordance with ISO 80000-landISO 80000-9.Furthermore,whererelevant,therequirements as specified in 4.1.4, 4.1.5 and 4.1.6 shall be met for the various reagents used for staining in biology.
4.1.4 Information supplied by the manufacturer with reagents used for staining in biology
Information supplied by the manufacturer with reagents used for staining in biology shall be in accordance with ISO 80000-1 and ISO 80000-9. In formation shall be provided regarding warning and precautions. Iso 18113-1 and ISO 18113-2 regarding warnings and precautions apply. Furthermore, where relevant, the requirements as specified in 4.1.2. 4.1,3 and 4.1.4 shall be met for the various reagents used for staining in biology.
4.1.5 Product name
The product name shall, where relevant, include CAS-registry number and Colour Index name and number.
NOTE 1 CAS-registry numbers are the Chemical Abstracts Service registry numbers. These are unique numerical code numbers assigned to chemical substances indexed by Chemical Abstracts.
NOTE 2 The Colour Index gives a 5-digit number, the C.J. number and a specially constructed name to most dyes.BS EN ISO 19001:2013 pdf free download.