FSH operates in accordance with the following:
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European Medical Device Directive 93/42/EEC (amended).
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Quality Management Standards (ISO 13485:2003).
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CE Production Quality Assurance (British Standard Institute - registered 0086).
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European Personal Protective Equipment Directive 89/686/EEC.
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CE-type product examination (Inspec Certification Ltd - registered 0194).
Certificates are available upon request, here.