Compliance & Quality Standards

Get in touch

Contact Us

Compare our products

Compare Products

Compliance

The Sterimedix mission is to create high-quality, affordable medical devices to improve quality of life for all

Quality/Regulatory Compliance:

Quality and Regulatory compliance requirements for Medical Device companies are ever-changing and Sterimedix Limited is focussed on ensuring we meet all relevant standards applicable to our business.

For more information visit our Quality Standards Page.

Anti-Bribery & Codes of Business Practice:

Sterimedix is committed to conducting all business activities in an honest and ethical manner.

In accordance with the Bribery Act 2010 we operate governance by implementing and enforcing robust policies and procedures to guard against any illegal behaviour.

Sterimedix Limited adheres to the Bausch Health policies relating to Bribery and Business Ethics.

For more information please contact us.

 

Single-use Ophthalmic and Aesthetic Medical Devices

QUALITY STANDARDS

Quality and Regulatory compliance requirements for Medical Device companies are ever changing and Sterimedix Limited is focussed on ensuring we meet all relevant standards applicable to our business. The Company’s products are registered in all the major markets worldwide. For more information please do not hesitate to contact us.

▸ EN ISO 13485 2016 – Certificate No Q5 105847

▸ MDD 93-42-EEC Annex II – Certificate No G1 105847

▸ MDD 93-42-EEC Annex V – Certificate No G2MS 105847

▸ MDD 93-42-EEC Annex V – Certificate No G2M 105847

▸ MDD 93-42-EEC Annex V – Certificate G2S 105847

Single-use Ophthalmic and Aesthetic Medical Devices

SINGLE USE

Single Use Medical Devices

All Sterimedix Products are labelled as Single Use.

How do I know if a device is for single use?

It will have the symbol (see left) on the packaging or on the device itself.

What does single-use mean?

It means DO NOT REUSE. A single-use device should be used on a single patient during a single procedure, and then discarded safely. It should not be reprocessed and used again, even on the same patient.

Why shouldn’t a single-use device be reused?

Serious incidents have been reported relating to the reuse of single-use devices. Reuse is unsafe because of the risk of:

• Cross-infection resulting from the inability to effectively clean and decontaminate a device due to its design.

• Endotoxin reaction resulting from excessive bacterial breakdown products which cannot be removed by cleaning.

• Patient injury caused by the failure of the device following reprocessing. Products that are not designed for multiple-use may not withstand reprocessing adequately as a result of material alteration, embrittlement or fatigue. Sharp edges will become dulled, the lumen of fine tubes may be blocked, and moving parts may not function properly.

• Chemical burns or sensitisation as a reaction to the chemicals or decontaminants which may be absorbed by the device during reprocessing.