11.080.10 – Sterilizing equipment – PDF Standards Store ?u= Wed, 06 Nov 2024 02:54:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 ?u=/wp-content/uploads/2024/11/cropped-icon-150x150.png 11.080.10 – Sterilizing equipment – PDF Standards Store ?u= 32 32 JIS T 7329:2008 ?u=/product/publishers/jis/jis-t-73292008/ Wed, 06 Nov 2024 02:54:32 +0000 Washer sterilizers for medical use
Published By Publication Date Number of Pages
JIS 2008-06-25 33
]]> Washer sterilizers for medical use
Published By Publication Date Number of Pages
JIS 2008-06-25 33
]]> JIS T 7324:1989 ?u=/product/publishers/jis/jis-t-73241989/ Wed, 06 Nov 2024 02:54:30 +0000 High-Pressure Steam Sterilizers for Medical Use (Small Size)
Published By Publication Date Number of Pages
JIS 1989-06-01 14
]]> High-Pressure Steam Sterilizers for Medical Use (Small Size)
Published By Publication Date Number of Pages
JIS 1989-06-01 14
]]> JIS T 7323:1989 ?u=/product/publishers/jis/jis-t-73231989/ Wed, 06 Nov 2024 02:54:30 +0000 Ethylene Oxide Gas Sterilizers for Medical Use
Published By Publication Date Number of Pages
JIS 1989-06-01 15
]]> Ethylene Oxide Gas Sterilizers for Medical Use
Published By Publication Date Number of Pages
JIS 1989-06-01 15
]]> JIS K 3824:2012 ?u=/product/publishers/jis/jis-k-38242012/ Wed, 06 Nov 2024 02:32:25 +0000 Testing methods for determining endotoxin rejection of ultrafiltration modules
Published By Publication Date Number of Pages
JIS 2012-10-22 15
]]> This Standard specifies the testing methods for determining endotoxin rejection of ultrafiltration modules by using the endotoxin test liquid originated from coliform bacillus of S-type (Escherichia coil 0111, etc.) as endotoxin (bacteriotoxin).

NOTE: The testing apparatus for determining endotoxin rejection used for this test (hereafter referred to as the "apparatus") may also be used for the test for determining bacterial rejection specified in JIS K 3823

]]> JIS K 3823:2012 ?u=/product/publishers/jis/jis-k-38232012/ Wed, 06 Nov 2024 02:32:24 +0000 Testing methods for determining bacterial rejection of ultrafiltration modules
Published By Publication Date Number of Pages
JIS 2012-10-22 18
]]> This Standard specifies the testing methods for determining bacterial rejection of ultrafiltration modules using Brevundimonas diminuta as the challenge organism.

NOTE: The testing apparatus for determining bacterial rejection used for this test (hereafter referred to as the "apparatus") may also be used for the test for determining endotoxin rejection specified in JIS K 3824.

]]> JIS K 3803:1990 ?u=/product/publishers/jis/jis-k-38031990/ Wed, 06 Nov 2024 02:32:17 +0000 Testing Methods for Determining Aerosol Retention of Depth Filter for Air Sterilization
Published By Publication Date Number of Pages
JIS 1990-01-01 8
]]> Testing Methods for Determining Aerosol Retention of Depth Filter for Air Sterilization
Published By Publication Date Number of Pages
JIS 1990-01-01 8
]]> JIS K 3801:2000 ?u=/product/publishers/jis/jis-k-38012000/ Wed, 06 Nov 2024 02:32:16 +0000 Test Method of HEPA Filters for Microbiological Use
Published By Publication Date Number of Pages
JIS 2000-01-20 9
]]> Test Method of HEPA Filters for Microbiological Use
Published By Publication Date Number of Pages
JIS 2000-01-20 9
]]> ISO/TS 15883-5:2005 ?u=/product/publishers/iso/iso-ts-15883-52005/ Wed, 06 Nov 2024 01:27:11 +0000 Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy
Published By Publication Date Number of Pages
ISO 2005-11 80
]]> ISO/TS 15883-5:2005 includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards.

The inclusion of the test soils and methods in ISO/TS 15883-5:2005 does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy.

Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil.

NOTE 1 The test soils and methods included in ISO/TS 15883-5:2005 are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing ISO/TS 15883-5:2005. They have been edited only to provide a uniform format within ISO/TS 15883-5:2005.

NOTE 2 An example of this is the use of the peroxidase test to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in ISO/TS 15883-5:2005). See also ISO 15883-1:2005, Annex D.

]]> ISO 15883-6:2011 ?u=/product/publishers/iso/iso-15883-62011/ Tue, 05 Nov 2024 21:45:29 +0000 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Published By Publication Date Number of Pages
ISO 2011-04 14
]]> ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.

The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

]]> ISO 15883-7:2016 ?u=/product/publishers/iso/iso-15883-72016/ Tue, 05 Nov 2024 21:45:29 +0000 Laveurs désinfecteurs — Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles, non invasifs et non critiques et des équipements de soins de santé
Published By Publication Date Number of Pages
ISO 2016-02 40
]]> ISO 15883-7:2016 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d'un seul cycle standard, d'articles réutilisables tels que les suivants:

a) les cadres de lit;

b) les tables de chevet;

c) les chariots de transport;

d) les récipients;

e) les tables d'opération;

f) les récipients de stérilisation;

g) les sabots médicaux;

h) les fauteuils roulants et dispositifs auxiliaires pour les personnes handicapées.

ISO 15883-7:2016 spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires, qui peuvent être nécessaires pour atteindre les performances requises.

Les dispositifs identifiés dans les domaines d'application de l'ISO 15883-2, l'ISO 15883-3, l'ISO 15883-4 et l'ISO 15883-6 ne relèvent pas du domaine d'application de la présente partie de l'ISO 15883.

Le présent document spécifie également les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, les essais de fonctionnement, la validation (qualification de l'installation, qualification opérationnelle et qualification des performances lors de la première installation), le contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et après des réparations importantes.

NOTE Les LD relevant de la présente partie de l'ISO 15883 peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs thermosensibles réutilisables, selon les recommandations du fabricant du dispositif.

Les exigences de performance spécifiées dans la présente partie de l'ISO 15883 ne peuvent pas garantir l'inactivation ou l'élimination du ou des agents pathogènes (protéine du prion) à l'origine des encéphalopathies spongiformes transmissibles.

]]>