Medical devices and cosmetic products new Standards


18 February 2011

Sterilization of health care products – Dry heat – Requirements for the development, validation, and routine control of a sterilization process for medical devices, ISO 20857:2010

ISO 20857 promotes good sterilisation practices. Manufacturers, laboratories, regulators, and healthcare practitioners worldwide can use ISO 20857 to ensure that health products are sterile, which can be crucial to the safety of patients.

ISO 20857:

  • promotes good practices to prevent infections and promote patient health
  • provides clearly defined requirements for healthcare product sterilisation processes and related equipment
  • aims to reduce the risk of patient exposure to potentially pathogenic microorganisms
  • applies both to reusable health care products that are reprocessed by health care providers and to single-use products that are sterilised as part of the manufacturing process and are shipped in a sterile state.

Cosmetics – Microbiology – Guidelines for the risk assessment and identification of microbiologically low-risk products , ISO 29621:2010

ISO 29621:2010 is a new Standard to reduce contamination in cosmetic products.

There are many ways in which a cosmetic product can be contaminated by microorganisms. These microorganisms then multiply to produce high bacterial counts that can cause adverse effects on product quality and consumer health, ranging from infections to severe allergic reactions. Cosmetic industry and regulatory agencies can use ISO 29621 to identify which levels and types of contamination represent a health hazard and which are safe.

Order ISO 29621:2010 (hard copy) or ISO 20857:2010 (hard copy) from You can order PDFs of ISO Standards by calling 0800 782 632 during business hours or emailing

== ENDS==

Media enquiries

Shona Weller
Standards New Zealand
(04) 498 3986

About Standards New Zealand

Standards New Zealand is the operating arm of the Standards Council, and part of New Zealand’s standards and conformance infrastructure. Standards New Zealand is an autonomous Crown entity responsible for managing the development and distribution of Standards across a range of sectors nationally.

Standards New Zealand is a self-funded, not-for-profit organisation, relying on revenue primarily from contracts with sponsors to develop Standards, and from sales of Standards publications. Our independence helps us facilitate a cross section of stakeholders’ contributions to the development of Standards, and ensure that each Standard meets the needs of end users.

Stay in touch

Subscribe to Standards New Zealand’s monthly e-magazine Touchstone at for the very latest news on Standards.

The question is not what you gain from standardisation, it's what you lose without it.