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.
Who is ISO 11978+A1 for?
ISO 11978+A1 on ophthalmic optics labelling for contact lenses and contact lens care products is useful for:
- Manufacturers of ophthalmic optics products
- Ophthalmologists
- Regulatory authorities
- Test centres
Why should you use ISO 11978+A1?
The labelling of contact lenses and contact lens care products needs to comply with national laws, regulations, or guidelines that might exist in countries throughout the world, where national laws and labelling requirements exist. ISO 11978+A1 attempts to harmonize requirements.
ISO 11978+A1 guidelines help you with the information to be supplied and directions to use. This lets ophthalmologists guide their patients correctly. Appropriate ophthalmic optics labelling also ensures the correct and safe use of contact lenses and contact lens care products by the end-users.
