Palvelualojen työnantajat PALTA

 

This document defines technical considerations needed for monitoring unmanned store operations. Technical considerations include the platform, data elements, and interface needed to collect and analyse information from logistics bases, facilities, devices, and other components of unmanned stores. Here, the platform may be designed on a cloud -based system. The Scope Clause 1 is a mandatory element of the text.For rules on the drafting of the Scope, refer to the ISO/IEC Directives, Part 2:2021, Clause 14.

 

This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD conforming with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD conforming with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2024, 4.1.5). NOTE 3 The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 4 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein or other protein in a manner that can inhibit its removal or inactivation from the load or WD. NOTE 5 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

 

This document defines technical concepts for unmanned stores and classifies them according to the degree of autonomy in their operations and/or services. It includes a definition, relevant actors, and a classification of unmanned stores. It also outlines the detailed operations and services by autonomy level, including those at unmanned stores.

 

ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; use with vacuum.

 

ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.

 

This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

 

 

1.1 This document specifies requirements for low-pressure hose assemblies intended for the following: gases and gas mixtures intended for medical use, — gases for driving surgicial tools, — excess gas for AGSS, — vacuum. NOTE AGSS removes excess gases from an anaesthetic workstation. 1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa, for vacuum systems at pressures not greater than 60 kPa absolute and for AGSS from -30 kPa to 10 kPa relative to ambient pressure. 1.3 This document does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies, which can be found in national standards or in ISO 18082 [1], iso:proj:67451ISO 9170-1:2017 and iso:proj:42056ISO 9170-2 . NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA C-9 [2]. NOTE 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified in AS 2902:2005 [3] and NEN 8877:2024 [4]. NOTE 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in ISO 18082 [1]. NOTE 4 Terminal units designed for quick connectors are specified in iso:proj:67451ISO 9170-1:2017. NOTE 5 Terminal units for anaesthetic gas scavenging systems are specified in iso:proj:42056ISO 9170-2. 1.4 This International Standard does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools. 1.5 This International Standard does not specify the intended uses of hose assemblies. NOTE Environmental aspects are dealt with in Annex B.

 

1.1 This International Standard specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. 1.2 This International Standard specifies NIST connectors intended for use with the following medical gases: oxygen; — nitrous oxide; — medical air; — helium; — carbon dioxide; — xenon; — specified mixtures of the gases listed above; — oxygen 90+ (O290+); — air for driving surgical tools; — nitrogen for driving surgical tools; and for use with vacuum. NOTE 1 Low-pressure hose assemblies for medical gases and vacuum are specified in ISO 5359 [4]. NOTE 2 ISO 4135:2022/DAmd 1.2 [5] will incorporate a definition for oxygen 90+. 1.3 The information to be supplied by the manufacturer is excluded from the scope of this International Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted. NOTE Environmental aspects are dealt with in each International Standard concerning medical devices fitted with NIST connectors.

 

This document provides guidelines for the strategies, operations and contents related to the identification of hazards and risks, risk assessment, risk reduction, and safety measures addressing risks in unmanned stores. This standard is applicable to all types of unmanned stores excluding specific industries or sectors.