Pregled nacrta

The vocabulary in ISO 7369:2004 is out of date and that this standard needs to be revised to update the definitions in accordance to EN ISO 10380, EN 14585 and the PED (Pressure Equipment Directive).

Revision of EN ISO 7369:2004 under VA/CEN lead with Eric Winterbert as project leader is accepted by ISO/TC 5/SC 11 (Resolution 1/2016).

The exact scope of the revision will be clarified by the project group before launching the NWIP ballot.

Part 2 of ISO 25539 specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

NOTE          Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this standard, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.

Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this standard, but test methods are not described for the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this standard. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539 (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters — Sterile and single-use catheters, specific to the use of balloons with vascular stents.

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow diverters are within the scope of this standard, but comprehensive requirements and testing are not described for these devices.

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive with respect to the drug-eluting properties of these devices.

NOTE          Vascular device-drug combination products are within the scope of ISO 12417-1 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products.

Although absorbable stents and stents with absorbable coatings are within the scope of this standard, this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE          Absorbable implants are within the scope of ISO/TS 17137 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.

Although coated stents and coated stent systems are within the scope of this standard, this standard is not comprehensive with respect to coatings.

NOTE          Some coating properties are within the scope of ISO 17327-1 Non-active surgical implants — Implant coating — Part 1: General requirements.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.

This document specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document addresses the following:

—    test sample selection;

—    selection of representative portions from a medical device;

—    test sample preparation;

—    experimental controls;

—    selection of, and requirements, for reference materials;

—    preparation of extracts.

This document is not applicable to live cells, but can be relevant to the material or medical device components of combination products containing live cells.

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

New clause 18

This Part 12 of EN 13445 series specifies requirements for unfired pressure vessels and their parts made of copper and copper alloys (see 5.2) in addition to the general requirements for unfired pressure vessels in EN 13445-1:2014 to EN 13445-5:2014.
NOTE 1 Cast materials are not included in this version. Details regarding cast materials will be subject to an amendment to or a revision of EN 13445 series.
NOTE 2 Soldered connections are presently not considered.

This part of ISO 8501 specifies a series of preparation grades for steel surfaces after removal/partial removal of water-soluble contaminants, rust, previous paint coatings and other foreign matter by high-pressure water jetting. The various grades are defined by written descriptions together with photographs that are representative examples within the tolerances for each grade as described in words. In addition, this part of ISO 8501 specifies both initial surface conditions and after-cleaning flash rust grades, also defined by written descriptions together with representative photographic examples.

NOTE 1       Examples of foreign matter, other than paint residues, are salt, grime, dirt, mill scale, oil, grease and marine growth, e.g. algae.

This part of ISO 8501 relates the cleanliness of the surface to its visual appearance. In many instances, this is sufficient for the purpose but, for coatings likely to be exposed to severe environments, such as water immersion and continuous condensation conditions, consideration should be given to testing for soluble salts and other invisible contaminants on the visually clean surface by the physical and chemical methods which form the subjects of the various parts of ISO 8502.

The roughness characteristics of the surface should also be considered by reference to ISO 8503, although it must be noted that preparation by high- pressure water jetting does not create a profile or significantly change an existing profile.

This part of ISO 8502 describes a method of extracting, for analysis, water soluble contaminants from a surface by use of flexible cells in the form of adhesive patches or sleeves which can be attached to any surface, regardless of its shape (flat or curved) and its orientation (facing in any direction, including downwards).

The method described is suitable for use in the field to determine the presence of water soluble contaminants before painting or a similar treatment.

This part of ISO 8502 does not cover the subsequent analysis of the contaminants that have been dissolved off. Methods of analysis suitable for field use are described in other parts of ISO 8502.

NOTE          The extraction method might give a false negative or not take all the water-soluble material off the surface because of: (1) Soluble materials hiding in the crevices or under folds of metal; (2) Soluble materials under corrosion layers, passivation layers produced by corrosion inhibitors, oil, grease, or other non-visible thin films.

This part of ISO 8502 describes a field method for the assessment of the surface density of various water-soluble salts on steel surfaces, before and/or after surface preparation, by conductometric determination. The individual surface densities of the salt composition like chlorides, sulphates, sodium, etc, cannot be determined by this method. This method assesses only contaminants that will form an electrolyte (ions) when in contact with water. These represent the greater part of the contaminants.

This document is one of a series of standards describing the characteristics for identification cards as defined in the definitions clause and the use of such cards for international interchange.
This document specifies requirements for a high coercivity magnetic stripe (including any protective overlay) on an identification card and encoding technique. It takes into consideration both human and machine aspects and states minimum requirements.
Coercivity influences many of the quantities specified in this document but is not itself specified. The main characteristic of the high coercivity magnetic stripe is its improved resistance to erasure. This is achieved with minimal probability of damage to other magnetic stripes by contact while retaining read compatibility with magnetic stripes as defined in ISO/IEC 7811-2.
This document provides for a card capacity of approximately 10 times that of a card conforming to ISO/IEC 7811-6. The number of tracks has been increased to 6, each track being approximately half the width of tracks conforming to ISO/IEC 7811-6, located so that readers designed to read these high density tracks will also be able to read cards conforming to ISO/IEC 7811-2 and ISO/IEC 7811-6. Data is encoded in 8 bit bytes using the MFM encoding technique. Data framing is used to limit error propagation and error correction techniques further improve reliability of reading.
It is the purpose of the ISO/IEC 7811 series of standards to provide criteria to which cards shall perform. No consideration is given within these standards to the amount of use, if any, experienced by the card prior to test. Failure to conform to specified criteria is negotiated between the involved parties.
ISO/IEC 10373-2 specifies the test procedures used to check cards against the parameters specified in this document.
NOTE Numeric values in the SI and/or Imperial measurement system in this document may have been rounded off and are consistent with, but not exactly equal to each other. Using either system is correct but intermixing or reconverting values can result in errors. The original design was made using the Imperial measurement system.

This part of EN ISO 19014 specifies general principles for software design, test and signal transmission requirements of safety‐related parts of machine‐control systems (MCS) in earth‐moving machinery and its equipment, as defined in EN ISO 6165.

This document specifies requirements and test methods for the qualification of laser beam machines
for metal powder bed additive manufacturing for aerospace applications.

This standard specifies requirements for the machine operator qualification of powder bed based laser
beam machines for additive manufacturing of metallic parts.
This document is applicable if the machine operator qualification testing is required by contract or by
application standards.
Note: The term "operator" refers to the machine operator not to the programmer.

This document applies to central compressed air source equipment for dental compressed air used in dentistry. It specifies functional requirements for compressed air source equipment and quality requirements for the dental compressed air produced by the compressed air source equipment.
This International Standard specifies the purity level of dental compressed air and test procedures for central compressed air source equipment and test procedures for the quality requirements for dental compressed air.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the compressed air source equipment.
This International Standard only applies to central compressed air source equipment located outside of the dental treatment room.
Dental compressors located in the dental treatment room and facility piping are excluded from the scope of this International Standard.

This International Standard specifies four methods of test of textile floor coverings (with or without an underlay, see Clause 9) using the Lisson Tretrad machine.

—    test A: determination of mass loss of textile floor coverings, also used to assess fibre bind of synthetic pile carpets;

—    test B: determination of stair nosing appearance change of textile floor coverings;

—    test C: determination of fibre bind on synthetic loop pile carpets;

—    test D: determination of fibre bind (hairiness) on needled floor coverings and floor coverings without pile.

This document provides basic requirements for piston type pneumatic linear actuators for industrial valve, both double acting and single acting, used for on-off and modulating control duties.
It includes criteria, method and guidelines for design, qualification, corrosion protection, control and testing.
It does not apply to diaphragm actuators and to pneumatic actuators which are integral parts of control valves.
Other requirements, or conditions of use, different from those indicated in this document, are subject to negotiations, between the purchaser and the manufacturer/supplier, prior to order.