The Bureau of Indian Standards (BIS) has issued Amendment No. 1 to IS/ISO 11979-4:2008, which deals with the labelling and information requirements for intraocular lenses used in ophthalmic implants. This amendment, which was notified on 21st April 2025 officially comes into force on 15th April 2025.
The existing version of the standard will remain valid until 14th October 2025, providing a transition period during which both the previous and amended versions will be in effect.
The key update under this amendment aims to enhance clarity and ensure that labelling for intraocular lenses meets the highest safety and regulatory standards, benefiting both manufacturers and end-users in the healthcare sector.
Details of the amendment are as follows:
| Sl. No. | Indian Standard No., Year & Title | Amendment No. & Date | Date of Establishment | Validity of Previous Version |
| 1 | IS/ISO 11979-4:2008 — Ophthalmic Implants — Intraocular Lenses — Part 4: Labelling & Info | Amendment No. 1, April 2025 | 15 April 2025 | 14 October 2025 |
