Pregled nacrta

This part of ISO 2812 specifies a method for determining the resistance of an individual-layer or multi-layer system of coating materials to the effects of water by partial or full immersion.

This method enables the determination of the effects of water on the coating and, if necessary, the assessment of the damage to the substrate.

This part of ISO 5398 describes a method for the determination of chromium in aqueous solution obtained from leather. This is an analysis for total chromium in leather; it is not compound specific or specific to its oxidation state.

This method describes the determination of chrome by iodometric titration and is to be applicable to chromium-tanned leathers which are expected to have chromic oxide contents in excess of 0,3 %. Two different methods are described as alternatives for obtaining chromium in a suitable solution. It is appropriate to use either method.

This part of ISO 5398 describes a method for the determination of chromium in aqueous solution obtained from leather. This is an analysis for total chromium in leather; it is not compound specific or specific to its oxidation state.

This method describes the determination of chromium by inductively coupled plasma – optical emission spectrometry and is applicable to leathers which are expected to have chromic oxide contents in excess of 1 mg/kg. Two techniques for the preparation of the solution to be analysed are included. In the case of dispute, the wet oxidation technique is to be used.

This European Standard specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868‑9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

The materials specified in this part of EN 868 are intended for single use only.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868‑2, −3, 4- −6 and −7. Please consider that a positive ballot on prEN 858‑10 during enquiry includes the approval of the revised scope.

This European Standard specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

The materials specified in this part of EN 868 are intended for single use only.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868-2, −3, 4- −6 and −7. Please consider that a positive ballot on prEN 858‑5 during enquiry includes the approval of the revised scope.

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

NOTE 1       The need for a packaging material inside the container is determined by the manufacturers and users.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

NOTE 2       When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating temperature.

NOTE 3       When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868‑2, −3, 4- −6 and −7. Please consider that a positive ballot on prEN 858‑8 during enquiry includes the approval of the revised scope.

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

NOTE 1       The need for a packaging material inside the container is determined by the manufacturers and users.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

NOTE 2       When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating temperature.

NOTE 3       When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868‑2, −3, 4- −6 and −7. Please consider that a positive ballot on prEN 858‑8 during enquiry includes the approval of the revised scope.

This European Standard provides the reaction to fire classification procedure for all construction products, including products incorporated within building elements.

Products are considered in relation to their end use application.

This document applies to three categories, which are treated separately in this European Standard:

—    construction products, excluding floorings and linear pipe thermal insulation products;

—    floorings;

—    linear pipe thermal insulation products.

This European Standard provides the reaction to fire classification procedure for electric cables.

NOTE          For the purpose of this European Standard the term “electric cables” covers all power, control and communication cables, including optical fibre cables.

This European Standard specifies requirements for roofing and cladding products used for assembly into coverings for wall claddings, linings and pitched roofs, made from aluminium sheet with or without additional surface treatment (organic coating or anodising).

The standard establishes general characteristics, definitions and labelling of the products, together with requirements for the materials from which the products can be manufactured. It is intended to be used either by manufacturers to ensure that their products comply with the requirements or by purchasers to verify that the products comply before they are despatched from the factory. It specifies the requirements for products which enable them to meet all normal service conditions. Products can be prefabricated or semi-formed products as well as strip, coil and sheet for on-site-formed applications (e.g. standing seam roofs).

The standard applies to all discontinuously laid and fully supported roofing and cladding products made of aluminium sheets. No requirements for supporting construction, design of roof system and execution of connections and flashings are included.

The standard does not apply to self-supporting aluminium sheets that are covered by EN 508‑2.

This European Standard specifies a method for measuring the steady-state liquid flow through a geosynthetic barrier, used to contain liquids in long-term applications.

The test method and described apparatus allow the measurement of flows accurately down to 10-6 m3/m2/day. In particular circumstances where testing indicates that values obtained for a geosynthetic barrier lie below the threshold of sensitivity of this test method, then the value of liquid flow is declared as being less than10-6 m3/m2/day.

Due to its long duration this test method is not suitable for production control testing.

Clay geosynthetic barriers cannot be tested with this apparatus.

This International Standard specifies safety requirements and their verification for the design and construction of hand-held, integrally-driven combustion engine hedge trimmers, hereafter referred to as “hedge trimmers”, designed to be used by a single operator for trimming hedges and bushes while utilizing one or more linear reciprocating cutter blades.

This International Standard is also applicable to ‘split-boom’ type hedge trimmers and to multi-purpose machines when configured as a hedge trimmer.

It establishes methods for the elimination or reduction of hazards arising from the use of the hedge trimmers. In addition, it specifies the type of information to be provided by the manufacturer on safe working practices.

This International Standard deals with all significant hazards, hazardous situations and events relevant to hand-held powered hedge trimmers when they are used as intended (see Clause 4).

This International Standard does not deal with low noise design. It is not applicable to hedge trimmers with an engine displacement over 80 cm3, nor is it applicable to hedge trimmers manufactured before the date of its publication

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These people may include the person(s) managing the audit programme, auditors and audit teams.

It is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit programme.

The application of this document to other types of audits (including against criteria related to product services, contracts, supply chains) is possible, provided that special consideration is given to the specific competence needed.

This European Standard specifies a method for measuring the tensile properties of a fibre optic cable.
It shall be used together with EN 3745-100.

This European Standard specifies the single-pole temperature compensated arc fault circuit breakers with or without signal contacts, rated from 3 A to 25 A and used in aircraft on-board circuits. In any operating state a "trip-free" tripping is ensured. These items are designed to protect aircraft wiring system from circuit overload and arc faults. It describes specific environmental, electrical and mechanical characteristics and the stringency of tests to be applied according to test methods of EN 3841-100.
If the design of the arc fault circuit breakers contains software or complex hardware, as a minimum, the software and hardware shall be developed in accordance with RTCA DO-178B or C, DAL C and RTCA DO 254, DAL C, respectively.
These arc fault circuit breakers are intended for use in aircraft with electrical supplies in accordance with EN 2282.

  This document specifies the testing instruments and procedure for filtration efficiency of flat sheet filter media against airborne nanoparticles in the 20 – 500 nm range.

This part of ISO 12215 .applies to the scantlings determination of small craft with a hull length (LH) or Load line length (see Note) up to 24 m, and in intact condition:

¾      Its main core determines the local design pressures and stresses on monohull small craft and gives a panel of assessment methods.

¾      Its Annexes gives various possible methods to determine the scantlings of plating and stiffeners, both for monohulls and multihulls. Local pressures and stresses for multihulls are defined in ISO 12215-7.

It applies to small craft built from the following material

¾      fibre-reinforced plastics, either in single skin or sandwich construction;

¾      aluminium or steel alloys;

¾      glued wood or plywood (single skin or sandwich), excluding traditional wood construction;

¾      non reinforced plastics less than 6 m , using Annex D.

It applies to the following types of small craft:

¾      recreational craft including recreational charter vessels;

¾      other small craft for professional use (workboats),using clause 12 and Annex J.

It is not planned to be applicable to racing craft designed only for professional racing.

The assessment includes all parts of the craft that are assumed watertight or weathertight when assessing stability, freeboard and buoyancy in accordance with ISO 12217.

The scantling determination of windows, portlights, deadlights, hatches and doors, covered by ISO 12216, is excluded, but the structure supporting these elements shall be in accordance with this part of ISO 12215.

For the complete scantlings of the craft, this part of ISO 12215 shall be used, where relevant with Part 8 for rudders, Part 9 for appendages and Part 10 for rig loads and rig attachment.

Throughout this document, and unless otherwise specified, dimensions are in (m), Areas in (m²), masses in kg, forces in (N), moments in (Nm), Pressures in kN/m² (1kN/m²=1 kPa), stresses and elastic modulus in N/mm² (1N/mm²=1 Mpa). Max (a;b;c) means that the required value is the maximum of a, b, and c, and min(d;e;f) means the minimum of d, e, and f.

NOTE          The load line length is defined in the OMI "International Load Lines Convention 1966/2005", it may be larger than LH for craft with overhangs. This length also sets up, at 24 m, the lower limit of several IMO conventions.

This European Standard covers street cabinets for up to 1440 fibre connections for use in outside plant environments under category A according to EN 61753-1:Ed2.

This document contains the initial, start of life dimensional, optical, mechanical and environmental
performance requirements of a fully installed passive optical fibre street cabinet, in order for it to be categorised as an EN standard product.

The street cabinet is a housing containing modular fibre management systems with splice trays for various fibre separation levels  and connector mounting plates. The street cabinet may contain one or more of the following:
storage and/or routing of cable;
through-box/uncut fibre, cable storage;
connectors
passive optical devices.

1.1 Inclusions
This International Standard specifies requirements for the development, validation and routine control
of an ethylene oxide sterilization process for medical devices in both the industrial and health care
facility settings, and it acknowledges the similarities and differences between the two applications.
NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety
measures. The major differences relate to the unique physical and organizational conditions in health care
facilities, and to the initial condition of reusable medical devices being presented for sterilization.
NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing
areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience.
The primary function of the health care facility is to provide patient care; medical device reprocessing is just one
of a myriad of activities that are performed to support that function.
NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize
large numbers of similar medical devices that have been produced from virgin material. Health care facilities,
on the other hand, must handle and process both new medical devices and reusable medical devices of different
descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of
cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International
Standard, alternative approaches and guidance specific to health care facilities are identified as such.
NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisturesensitive
medical devices that cannot be moist heat sterilized.
NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements
and provides guidance that can be applicable to other health care products.
1.2 Exclusions
1.2.1 This International Standard does not specify requirements for the development, validation and
routine control of a process for inactivating the causative agents of spongiform encephalopathies such
as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations
have been produced in particular countries for the processing of materials potentially contaminated with
these agents.
NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This International Standard does not detail a specified requirement for designating a medical
device as sterile.
NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”.
See for example EN 556–1 or ANSI/AAMI ST67.
1.2.3 This International Standard does not specify a quality management system for the control of all
stages of production of medical devices.
INTERNATIONAL STANDARD ISO 11135:2014(E)
© ISO 2014 – All rights reserved 1

ISO 11135:2014(E)
NOTE The effective implementation of defined and documented procedures is necessary for the development,
validation and routine control of a sterilization process for medical devices. Such procedures are commonly
considered to be elements of a quality management system. It is not a requirement of this International Standard
to have a full quality management system during manufacture or reprocessing. The necessary elements are
normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the
standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing
of medical devices. National and/or regional regulations for the provision of medical devices might require the
implementation of a full quality management system and the assessment of that system by a third party.
1.2.4 This International Standard does not specify requirements for occupational safety associated
with the design and operation of EO sterilization facilities.
NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations
may also exist.
NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of
regulations giving safety requirements for handling EO and for premises in which it is used.
1.2.5 This International Standard does not cover sterilization by injecting EO or mixtures containing
EO directly into packages or a flexible chamber.
NOTE See ISO 14937 for these types of EO processes.
1.2.6 This International Standard does not cover analytical methods for determining levels of residual
EO and/or its reaction products.
NOTE 1 For further information see ISO 10993-7.
NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for
the level of EO residues present on or in medical devices.

This document specifies two methods for measuring the stiffness and one method for the determination of the flexibility of rubber and plastics hoses and tubing when they are bent to a specific radius at sub-ambient temperatures.

Method A is suitable for non-collapsible rubber and plastics hoses and tubing with a bore of up to and including 25 mm. This method provides a means of measuring the stiffness of the hose or tubing when the temperature is reduced from a standard laboratory temperature.

Method B is suitable for rubber and plastics hoses and tubing with a bore of up to 100 mm and provides a means of assessing the flexibility of the hose or tubing when bent around a mandrel at a specified sub-ambient temperature. It can also be used as a routine quality control test.

Method C is suitable for rubber and plastics hoses and tubing with a bore of 100 mm and greater. This method provides a means of measuring the stiffness of the hose and tubing at sub-ambient temperatures. This method is only suitable for hoses and tubing which are non-collapsible.