BS EN ISO 11978:2017+A1:2020 PDF

Scope: What is ISO 11978+A1 about? ISO 11978+A1 discusses ophthalmic optics labelling with reference to contact lenses and contact lens care products. ISO 11978+A1 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products, to ensure the correct and safe use of these devices and their accessories. The information provided by the manufacturer is useful for both types of users of contact lenses: the eye care professional and the contact lens wearer. ISO 11978+A1 provides a suitable framework for developing labelling for contact lenses and contact lens care products. Conformance to the elements herein is intended to be sufficient for developing appropriate labelling for countries without existing laws or regulations for medical device labelling. Note: ISO 11978+A1 does not specify the format in which such information shall be provided. ...

BS EN ISO 11978:2017+A1:2020 history

2020 BS EN ISO 11978:2017+A1:2020 Ophthalmic optics. Contact lenses and contact lens care products. Labelling
2017 BS EN ISO 11978:2017 Ophthalmic optics. Contact lenses and contact lens care products. Labelling
2014 BS EN ISO 11978:2014 Ophthalmic optics. Contact lenses and contact lens care products. Labelling
2000 BS EN ISO 11978:2000 Ophthalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer