Pregled nacrta

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:

the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
the establishment of stability of the IVD reagent in use after the first opening of the primary container;
the monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain:
a)    to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;
b)    to demonstrate compliance with applicable statutory and regulatory food safety requirements;
c)    to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;
d)    to effectively communicate food safety issues to interested parties within the food chain;
e)    to ensure that the organization conforms to its stated food safety policy;
f)     to demonstrate conformity to relevant interested parties;
g)    to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.
All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials.
This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS.
Internal and/or external resources can be used to meet the requirements of this document.

This document specifies refinements for an application of EN ISO/IEC 27701 in a European context.
This document is applicable to the same entities as is ISO/IEC 27701: all types and sizes of organizations, including public and private 
companies, government entities and not-for-profit organizations, which are PII controllers and/or PII processors.
An organization can use this document for the implementation of the generic requirements and controls of EN ISO/IEC 27701 
according to its context and its applicable obligations.
Certification criteria based on these refinements can provide a certification model under ISO/IEC 17065 for processing operations 
performed within the scope of a privacy information management system according to EN ISO/IEC 27701, which can be combined 
with certification requirements for EN ISO/IEC 27701 under ISO/IEC 17021.

This document specifies requirements and provides guidance for risk management of AI systems. It specifies terminology, principles and a process for risk management.
The process described in this document intends to assist providers of AI systems to identify the hazards associated with the AI systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The process described in this document applies to risks to health, safety and fundamental rights associated with an AI system. The process described in this document is applied throughout the life cycle of the AI system.
This document requires providers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
This document is intended for use by organizations providing AI systems, regardless of their size, nature or location. This document is not intended for managing risk faced by organizations. This document is intended to support the organization in meeting applicable regulatory requirements.

This document addresses organizational and technical solutions aimed at ensuring the cybersecurity of high-risk AI systems over the life cycle, appropriate to the relevant circumstances and the risks. The technical solutions to address AI-specific vulnerabilities include, where appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying to manipulate the training dataset (data poisoning), or pre-trained components used in training (model poisoning), inputs designed to cause the model to make a mistake (adversarial examples or model evasion), confidentiality attacks or model flaws. This document provides objective criteria to enable decisions on whether a given technical or organizational solution adequately achieves a given vulnerability-related goal.

This document specifies product characteristics and test methods of mechanically operated locks and their locking plates.
This document covers mechanically operated locks and their locking plates which are either manufactured and placed on the market in their entirety by one producer or assembled from sub-assemblies produced by more than one producer and designed to be used in combination.
This document does not cover assessment of the contribution of the product to the fire resistance of specific fire resistance and/or smoke control door set assemblies.
This document is not applicable to mechanically/electromechanically cylinders, handles, locks for windows, padlocks, locks for safes, furniture locks or prison locks.
This document does not specify mechanically operated multipoint locks and their locking plates which are specified by EN 15685.

This document specifies product characteristics and test methods of mechanically operated multipoint locks and their locking plates.
This document covers multipoint locks their locking plates which are either manufactured and placed on the market in their entirety by one producer or assembled from sub-assemblies produced by more than one producer and designed to be used in combination.
This document does not cover assessment of the contribution of the product to the fire resistance of specific fire resistance and/or smoke control door set assemblies.
This document is not applicable to mechanically/electromechanically cylinders, handles, locks for windows, padlocks, locks for safes, furniture locks or prison locks.
This document does not specify mechanically operated locks or their locking plates which are specified by EN 12209.

This document specifies the procedure for the determination of the compressive strength of autoclaved aerated concrete.

This document specifies the safety requirements and test methods for slings and wraps which are designed to carry one or two children in one or more positions and secured to the carer's torso to allow for hands free operation when standing and/or walking.
If the sling or wrap has functions not covered in this document, reference can be made to the relevant European Standard.
This document does not cover garment or apparel carriers.
This document does not cover baby carriers designed for children with special needs.

This document is applicable to manually operated end cocks designed to cut-off the brake pipe and the main reservoir pipe of the air brake and compressed air system of rail vehicles; without taking the type of vehicles and track-gauge into consideration.
This document specifies requirements for the design, dimensions, testing and certification (qualification and/or type test), and marking.

This document is applicable for internally coated cylindrical and conical aluminium tubes, mainly used for the packing of pharmaceutical, cosmetic, hygiene, food or other household products.
The internal coating is used as a barrier to avoid any contact between aluminium and the product. This document defines the sodium chloride method to detect the electrolyte conductivity as one criterion for the quality of the internal coating.
NOTE The electrolyte conductivity of the internal coating is only one criterion for evaluation of the quality of an internal coating. It does not give any information on the quantity or size of any pores or uncoated areas, nor any hint on possible reactions between the aluminium tube and the product.
The electrolyte conductivity can never be used as the sole criterion for quality evaluation of the internal coating, but always with other parameters e.g. film thickness, acetone and/or ammonia resistance and of course results of enhanced stability studies.

This document specifies a method for the determination of the strength of the head welding of flexible laminate and extruded plastic tubes.
It is applicable to flexible laminate and extruded plastic tubes packaging applications.

This document specifies functional requirements and specific safety requirements in addition to the general safety standard EN 913 for gymnastic and vaulting boxes for individual or multifunctional use. This document also specifies requirements when multifunctional boxes are used in combination with accessories.