SIST ISO 16217:2020 PDF

Name: SIST ISO 16217:2020 — Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance
SKU: SIST ISO 16217:2020
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Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance

Название (английский):

SIST ISO 16217:2020

Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 12 мая 2020 г.
ICS:: 71.100.70
Технический комитет:: KDS - Cosmetics, chemical disinfectants and surface active agents

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Описание (английский):

This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products. This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 16217:2020 - "Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance" defines an in vivo water immersion procedure to evaluate the water resistance of sunscreen products. Designed to be used together with ISO 24444 (in‑vivo SPF determination), the standard specifies how to challenge applied sunscreens in a simulated swim environment and how to calculate post‑immersion and water‑resistance Sun Protection Factor (SPF) metrics.

Key topics and technical requirements

Scope and applicability

Applies to products intended for contact with human skin that absorb, reflect or scatter UV and are formulated to resist removal by water.

Test population

Minimum of 10 test subjects; specific informed consent (including water immersion duration and potential chill) is required in line with the Declaration of Helsinki.

Test area and application

Test sites are located on the back (between scapula line and waist) and must be fully immersed during the procedure. Product application follows ISO 24444 protocols.

Water immersion procedure

Room temperature: 20–26 °C. Water temperature: 30 ± 2 °C.
Use a simulated swim test device (spa/whirlpool design) as described in Annex A.
Immersion cycle: 20 minutes immersion (water circulated) followed by 5–20 minutes drying (no towelling). Repeat cycles for target water‑resistance durations (e.g., two cycles for 40 min, four cycles for 80 min).
Final drying: allow test areas to be free of visible droplets and dry for at least 15 minutes before UV exposure.

Positioning and safety

Subjects are seated to avoid contact of test sites with spa sides, other subjects, or direct water jet impingement.

Validation and calculation

Labs must validate the immersion procedure using the P2 high‑SPF reference sunscreen on a defined frequency (every 200 subjects or every 2 months) to ensure consistent post‑water immersion SPF results.
Definitions and calculations for individual water resistance SPF (SPFiwr), post‑water immersion SPF, and water resistance SPF (SPFwr) are provided; calculation integrates MED values as per referenced methods.

Applications and users

Cosmetic testing laboratories and clinical trial facilities for claim substantiation of water resistance.

Sunscreen manufacturers and formulators during product development, QA and regulatory submissions.

Regulatory authorities and standards bodies evaluating sun protection performance and labeling claims.

Third‑party certification and consumer safety organizations verifying in‑use durability of sun care products.

Related standards

ISO 24444:2019 - In vivo determination of SPF (mandatory companion standard).

ISO 18861 - Referenced for retention calculations (as cited in ISO 16217).

Keywords: ISO 16217:2020, water resistance, sunscreen testing, water immersion procedure, SPF, simulated swim test device, in vivo sun protection, post‑water immersion SPF.

SIST ISO 16217:2020 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 16217:2020

Cosmetics — Sun protection test methods — Water immersion procedure for determining water resistance

ISO 24444:2019

Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)

ISO 24444:2019/Amd 1:2022

Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF) — Amendmen…

SIST EN ISO 18861:2022

Cosmetics - Sun protection test methods - Percentage of water resistance (ISO 18861:2020)

SIST EN ISO 16217:2022

Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance (ISO 162…