SIST EN ISO 10801:2011 PDF

Name: SIST EN ISO 10801:2011 — Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)
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Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)

Название (английский):

SIST EN ISO 10801:2011

Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 30
Дата публикации:: 16 сентября 2011 г.
ICS:: 07.120
Технический комитет:: I13 - Imaginarni 13

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Описание (английский):

ISO 10801:2010 gives requirements and recommendations for generating metal nanoparticles as aerosols suitable for inhalation toxicity testing by the evaporation/condensation method. Its application is limited to metals such as gold and silver which have been proven to generate nanoparticles suitable for inhalation toxicity testing using the technique specified.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 10801:2010 (ISO 10801:2010) defines requirements and recommendations for generating metal nanoparticles as aerosols for inhalation toxicity testing using the evaporation/condensation method. The standard is intended for metals proven suitable with this technique (notably silver and gold). It describes generator performance, characterization, and reporting to support reproducible, controlled exposures for short- and long-term toxicity studies.

Key topics and technical requirements

Generation principle: evaporation of bulk metal followed by condensation to form aerosolized nanoparticles (example method for silver is given in Annex A).

Applicable materials: limited to metals with appropriate melting/evaporation behavior (e.g., silver, gold).

Particle properties: requirements and guidance on size range (particle sizes up to 100 nm are covered), number concentration, shape, purity/impurities, and stability for continuous studies (method shown to provide stability suitable for up to 90 days).

Characterization methods: use of differential mobility analysing systems (DMAS) and differential electrical mobility classifiers (DEMC) for particle size distribution; condensation particle counters (CPC) and filter sampling for number and mass concentration.

System requirements: capacity and control, exposure chamber atmosphere specifications (whole‑body, head‑only, nose‑only), and system operational safety.

Quality & reporting: requirements for documenting generator performance, sampling frequency, measurement methods, and a standardized test report to ensure reproducibility and regulatory acceptance.

Practical applications and users

Who uses it: toxicologists, occupational and environmental health researchers, inhalation exposure laboratories, nanomaterial manufacturers, regulatory testing facilities, and contract research organizations (CROs).

Where it applies: designing and conducting inhalation toxicity studies (acute, subacute, subchronic), validating nanoparticle generation systems, comparing exposure methods, and supporting regulatory submissions. The generated aerosols are suitable for animal exposure studies (whole‑body, head‑only, nose‑only) and for advanced in‑vitro methods (e.g., labs‑on‑a‑chip).

Practical value: promotes reproducible aerosol generation and standardized measurement procedures, enabling comparable toxicology data across labs and supporting occupational risk assessment for engineered metal nanoparticles.

Related standards

ISO/TS 27687 - Nanotechnologies: terminology for nano‑objects

ISO 15900 - Differential electrical mobility analysis (DMAS/DEMC)

ISO/IEC 17025 - Laboratory competence

OECD TG 403, 412, 413 - Inhalation toxicity test guidelines (acute to 90‑day studies)

Keywords: EN ISO 10801:2010, ISO 10801:2010, nanotechnologies, metal nanoparticles, inhalation toxicity testing, evaporation/condensation method, silver nanoparticles, gold nanoparticles, aerosol generation, DMAS, DEMC, CPC.

SIST EN ISO 10801:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 10801:2010

Nanotechnologies — Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/co…

ISO/TS 27687:2008

Nanotechnologies — Terminology and definitions for nano-objects — Nanoparticle, nanofibre and nanoplate

BS ISO 15900:2009

Determination of particle size distribution. Differential electrical mobility analysis for aerosol particles

ISO 6141:2015/Amd 1:2020

Gas analysis — Contents of certificates for calibration gas mixtures — Amendment 1: Cross reference list to I…