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ISO 12609-1-2013 pdf free download
ISO 12609-1-2013 pdf free download.Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 1:Specification for products
Equipements ophtalmiques de protection contre les sources lumineuses in tenses utilisées sur les animaux et les humains pour des applications médicales et cosmétiques — Partie 1: Specifications des produits.
When assessed in accordance with visual inspection, for those parts of the eye protector that come into contact with the skin, materials shall not be used which are known to be likely to cause skin irritation or any adverse effect on health.
Substances recommended for cleaning, maintenance or disinfection shall have no adverse effect on the eye protector and shall be known not to be likely to have any adverse effect upon the wearer, when applied in accordance with the eye protector manufacturer’s instructions.
Information claiming that the product is innocuous shall be examined.
The following are examples of documents that shall be provided for examination:
— materials specifications;
— safety data sheets relating to the materials;
— information relating to the suitability of the materials for use with food, in medical devices, or other relevant applications;
— information relating to toxicological, allergenic. carcinogenic, toxic to reproduction, or mutagenic investigations on the materials.
If the eye or face protector incorporates metallic components which are in direct and prolonged contact with the user during wear, these components shall optionally be tested for nickel release according to ISO/TS 24348. The nickel release shall be less than 0,5 pg/cm2/week.
NOTE National regulations may require assessment of nickel release to be mandatory.
When examined by a person with a visual acuity of at least 1,0 (6/6 or 20/20), when viewing without magnification but wearing the appropriate correction, if any, for near vision, there shall be no sharp edges, roughness or projection on any parts of the eye protector which are in contact, or potential contact, with the wearer, when the eye protector is worn, such as is likely to cause injury to the wearer.
Any part of the eye protector that can be adjusted, or removed by the wearer for the purpose of replacement (in accordance with the eye protector manufacturer’s instructions), shall be so designed and manufactured as to facilitate adjustment, removal and attachment without the use of tools.
Any adjustment system Incorporated within the eye protector shall be so designed and manufactured as not to become incorrectly adjusted without the wearer’s knowledge tinder the foreseeable conditions of use.ISO 12609-1-2013 pdf free download.
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