SIST EN 1041:2008
Information supplied by the manufacturer with medical devices
Information supplied by the manufacturer with medical devices
This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts
Die vorliegende Norm legt Anforderungen an Informationen fest, die von einem Hersteller für Medizinprodukte nach der EU-Richtlinie 90/385/EWG zu aktiven implantierbaren medizinischen Geräten und EU-Richtlinie 93/42/EWG zu Medizinprodukten zur Verfügung zu stellen sind. Es werden weder die verwendete Sprache für diese Informationen noch die Mittel festgelegt, mit denen die Informationen zu geben sind. Es ist ferner beabsichtigt, die besonderen Anforderungen der genannten EU-Richtlinien zu Medizinprodukten durch die Bereitstellung einer Anleitung zu ergänzen, wie bestimmte Anforderungen erfüllt werden können. Wenn diese Hinweise von einem Hersteller befolgt werden, so liefern sie eine Annahme der Übereinstimmung mit den relevanten grundlegenden Anforderungen hinsichtlich der bereitzustellenden Information.
Die vorliegende Norm schließt keine Anforderungen an die Bereitstellung von Informationen für In-vitro-Diag¬nostika ein, die von anderen genannten Normen abgedeckt werden (siehe Literaturhinweise).
ANMERKUNG Sofern nationale Umstellungen der Richtlinien die Mittel festlegen, mit denen Informationen zur Verfügung zu stellen sind, führt die vorliegende Norm nicht zu einer teilweisen Aufhebung dieser Anforderungen für das bestimmte Land.
Informations fournies par le fabricantavec les dispositifs médicaux
La présente norme spécifie les exigences concernant les informations à fournir par un fabricant de dispositifs médicaux d’après la réglementation dictée par la Directive du Conseil 90/385/CEE relative aux dispositifs médicaux implantables actifs et par la Directive du Conseil 93/42/CEE concernant les dispositifs médicaux. Elle ne spécifie pas la langue à utiliser pour ces informations ni les moyens par lesquels les informations sont fournies. Elle a également pour but de venir compléter les exigences spécifiques des Directives UE sur les dispositifs médicaux citées en donnant des indications sur la manière dont certaines exigences peuvent être satisfaites. Si un fabricant suit ces indications, celles-ci laissent à présumer de la conformité aux exigences essentielles relatives à la fourniture d'informations.
La présente norme ne couvre pas les exigences concernant la fourniture d’informations pour les dispositifs médicaux de diagnostic in vitro qui font l'objet d'autres normes d'étiquetage (voir Bibliographie).
NOTE Lorsque des transpositions nationales des directives précisent les moyens par lesquels les informations doivent être fournies, la présente norme ne propose pas de dérogation à ces exigences pour un pays particulier.
Informacije, ki jih proizvajalec priloži medicinskim pripomočkom
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Bereitstellung von Informationen durch den Hersteller eines MedizinproduktsInformations fournies par le fabricantavec les dispositifs médicauxInformation supplied by the manufacturer with medical devices11.040.01Medicinska oprema na splošnoMedical equipment in general01.110L]GHONHTechnical product documentationICS:Ta slovenski standard je istoveten z:EN 1041:2008SIST EN 1041:2008en,fr,de01-oktober-2008SIST EN 1041:2008SLOVENSKI
STANDARDSIST EN 1041:20001DGRPHãþD
SIST EN 1041:2008
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1041
August 2008 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:1998
English version
Information supplied by the manufacturer of medical devices
Informations fournies par le fabricant de dispositifs médicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European Standard was approved by CEN on 4 July 2008.
CEN andCENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:rue de Stassart, 36
B-1050 Brussels rue de Stassart, 35
B-1050 Brussels© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 1041:2008 E SIST EN 1041:2008
EN 1041:2008 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Requirements.6 4.1 General.6 4.2 Units, symbols and colours.6 4.3 Language and country identifiers.7 4.4 Dates.7 4.5 Device nomenclature.7 4.5.1 Identifiers of nomenclature.7 4.5.2 Device common terms.7 4.5.3 Batch code; lot number; batch number; lot code.7 5 Requirements for provision of information.7 5.1 General.7 5.2 Specific requirements.8 5.2.1 Applicability.8 5.2.2 Accessibility.8 5.2.3 Legibility.8 5.2.4 Availability.8 5.2.5 Security.8 5.2.6 Changes to information provided.8 6 Documentation.8 Annex A (informative)
Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended.9 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC).9 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC).15 Annex B (informative)
Guidance on alternative labelling for instructions for use (IFU).19 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC).20 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC).21 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC.22 Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC.23 Bibliography.24
SIST EN 1041:2008
EN 1041:2008 (E) 3
Foreword This document (EN 1041:2008) has been prepared by Technical Committee CEN/CLC TC 3 “Quality management and corresponding general aspects for medical devices”, the secretariat of which is held by NEN. This European Standard EN 1041:2008 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2009 and conflicting national standards shall be withdrawn at the latest by August 2011. This document supersedes EN 1041:1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B. Annex A provides practical guidance about the implementation of the essential requirements of the applicable Directives. For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
SIST EN 1041:2008
EN 1041:2008 (E) 4 Introduction The first edition of this standard was drafted in a period when the Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) and the Medical Device Directive (MDD) (93/42/EEC) were relatively new and the In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EEC) was not in existence. In addition, at the time the previous edition of this standard was adopted, the established method of providing information on, with, or otherwise in association with a device was by hard copy. Predominantly, this was printed copy on substrates such as paper, card, or plastic. Since the time of approval of the first edition of this standard on 18 January 1998, the MDD and AIMDD have been amended. In addition, other methods of provision of information have become freely available and widely used. The intention of this second edition is to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information as well as to update the requirements to reflect the changes to Directives 90/385/EEC and 93/42/EEC. In this standard, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007. The guidance reflects the desire to take into account different methods of provision of information, and it is intended that it should, as far as possible, be suitable for future methods of provision of information. The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means by which compliance can be tested by regulatory and inspection agencies. The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC. Annex B provides guidance on alternative labelling. SIST EN 1041:2008
EN 1041:2008 (E) 5
1 Scope This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 980, Symbols for use in the labelling of medical devices EN ISO 3166-1, Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2006) ISO 639-1, Codes for the representation of names of languages – Part 1: Alpha-2 Code ISO 1000, SI units and recommendations for the use of their multiples and of certain other units ISO 8601, Data elements and interchange formats – Information interchange – Representation of dates and times CEN/TR 15133, Nomenclature - Collective terms and codes for groups of medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 batch; lot defined amount of material or a number of devices, including finished product and accessories, that is processed in one process or a series of related processes
NOTE The defined amount of material or number of devices will normally be associated with a unique statement of conformity to a defined quality specification. 3.2 batch code; lot number; batch number; lot code unique identifier associated with a single batch or lot (see 3.1) SIST EN 1041:2008
EN 1041:2008 (E) 6 3.3 alternative labelling any form of electronically accessible information supplied by the manufacturer (see 3.4) related to a medical device such as CD/DVD-ROM, Internet or other mode 3.4 information supplied by the manufacturer
all material, however provided, relating to the identification, technical description and use of a medical device that is intended to ensure the safe, effective and compliant use of the device NOTE Shipping documents and promotional material are excluded from this definition when identification, technical description and use of a medical device are not intended to ensure the safe, effective and compliant use of the device.
3.5 medical device any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [Council Directive concerning medical devices (93/42/EEC), Article 1, paragraph 2 (a)] 3.6 user any person, legal or natural, for whom the information supplied (see 3.4) is intended 4 Requirements 4.1 General Product information and labelling shall be part of risk management procedures. NOTE 1
Due consideration should be given to the guidance provided in Annex A. NOTE 2
Product-related standards may require additional information to be supplied. 4.2 Units, symbols and colours Units used shall be SI units as specified in ISO 1000 or any other legal units. Symbols and safety-related identification colours shall be explained in the information supplied unless they are taken from harmonized standards, e.g. EN 980. SIST EN 1041:2008
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4.3 Language and country identifiers If the manufacturer decides to identify the language used in the information provided, for example to indicate to users the appropriate language in a multilingual document, this shall be done using the language codes given in ISO 639-1 and/or the plain text of the language (e.g. “English”). If the manufacturer decides to identify the country in the information provided, for example to indicate to users the appropriate customer service contact details for their country, this shall be done using the country codes given in EN ISO 3166-1 and/or the plain name of the country (e.g. “France”).
4.4 Dates Any human-readable date shall be expressed in the format YYYY-MM-DD, YYYY-MM or YYYY, in accordance with ISO 8601. NOTE
The choice of format will be determined by the requirements of the relevant Directives and the specific nature of the devices concerned. 4.5 Device nomenclature 4.5.1 Identifiers of nomenclature When it is required to include the identification of the generic device group or the device category in the information supplied with the device, this may be done using a nomenclature that is in compliance with EN ISO 15225. NOTE
For details of nomenclatures claimed to be in compliance with EN ISO 15225, see the Bibliography. 4.5.2 Device common terms When it is appropriate to identify collective terms for medical devices in the information supplied, for example common technology or common materials of construction, this shall be done using the terms and codes set out in CEN/TR 15133. 4.5.3 Batch code; lot number; batch number; lot code These shall consist of alphanumeric characters but may also be presented by other means, for example by using machine-readable codes. 5 Requirements for provision of information 5.1 General Any means of provision of information with medical devices shall take into account the intended users, the conditions of use and any issues specific to individual device types that are necessary for the safe and effective use of the device. This shall apply regardless of whether the specific requirements listed below apply to the device. The appropriate way of providing information shall be based on a risk assessment and in line with the training, experience and education of the intended users. SIST EN 1041:2008
EN 1041:2008 (E) 8 5.2 Specific requirements 5.2.1 Applicability These specific requirements shall be applicable to all devices to the extent that they are applicable to the specific device type concerned and to the means of provision of the relevant information. For example, the requirement to allow for a “use by” date is not applicable to devices that do not bear a “use by” date. 5.2.2 Accessibility The information presented with a device shall be accessible to intended users taking into account their age, education, knowledge and training. When appropriate, a specific means of provision may be restricted to users to whom it is particularly applicable. NOTE
This requirement may result in more than one means of provision being necessary. 5.2.3 Legibility Information intended for visual recognition shall be easily legible when viewed using normal vision, corrected if necessary, taking into account the specific size and conditions of use of the particular device. 5.2.4 Availability Information shall be available as long as reasonably necessary, taking the lifetime of the device into consideration. 5.2.5 Security As far as practicably possible, the medium of information provision shall be protected from corruption, degradation and deliberate change by those other than the manufacturer, whether malicious or not. If the user can readily identify faulty information, for example by virtue of damaged labels, advice on the action to take shall be provided. Where the damage to information is not readily apparent and/or the consequences of damage are not obvious, guidance shall be provided on how to maintain the security of the information and limit any adverse consequences. NOTE
When appropriate and relevant, manufacturers should consider if there are any preventative measures that can be taken to maintain information security in relation to customer service. 5.2.6 Changes to information provided Any changes to information provided for existing users shall be clearly communicated if they are important for patient safety. 6 Documentation Documentation relating to information provided shall be maintained in the technical documentation(s) relating to the device(s) that are the subject of the information. This may take the form of a specific section holding all the documentation or, alternatively, references to parts of a larger document where the information may be found, such as a quality manual. SIST EN 1041:2008
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Annex A (informative)
Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended
NOTE
This annex covers those non-active and active medical devices to which Council Directives 93/42/EEC and 90/385/EEC apply, hereinafter called medical devices. A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) NOTE
The left-hand column reproduces verbatim the requirements for information to be supplied by the manufacturer from Directive 93/42/EEC concerning Medical Devices given in the Essential Requirements in Annex I. The right hand column gives guidance and further explanation, as appropriate. Where no guidance is given, the Essential Requirements are not reproduced below. Requirements Information Requirements from the Council Directive concerning Medical Devices given in the Essential Requirements in Annex I Guidance General 8.7. The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.
In accordance with this standard, sterile devices are identified as such, preferably by the symbols
as given in EN 980 or the word stating this condition. Sterile devices should be prominently labelled by the appropriate symbols as given in EN 980. The definitions of sterile as given in EN 556-1 and EN 556-2 apply. Where both sterile and non-sterile versions of the same device from the same manufacturer are available in similar packaging and where, in such cases, the non-sterile device could be mistaken as sterile, it may be necessary for the safety of the patient, to provide a prominent statement of non-sterility. The similarity can either originate in the device itself or its packaging. 10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC. See 4.2, requirements, of this standard. 11.4.1. The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and user and on ways of avoiding misuse and of eliminating the risks inherent in installation.
Radiation is not limited to ionizing radiation. Other examples of radiation include heat and laser radiation (see also 89/618/Euratom). 13. Information supplied by the manufacturer
13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the Any information should be made available in a way that is understandable to the intended user and/or SIST EN 1041:2008
EN 1041:2008 (E) 10 Requirements Information Requirements from the Council Directive concerning Medical Devices given in the Essential Requirements in Annex I Guidance potential users, and to identify the manufacturer. patient. For complex equipment a user-friendly guide on how to check and operate the device in an emergency will be of benefit in addition to instructions of use. This information comprises the details on the label and the data in the instructions for use.
As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. When instructions for use are provided by means of a leaflet, the number of leaflets in a multiple pack is determined by the manufacturer, taking into consideration the use of the device. Information may also be provided by electronic means (see Annex B). Many devices, particularly active devices and many non-active class I devices, will not be supplied with packaging, apart from transit containers. In the absence of suitable packaging, any information should be supplied on labelling, accompanying documentation, or marking of the device, as necessary. Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or Class IIa if they can be used safely without any such instructions.
13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. Documentation can be the label and/or instructions for use. See 4.2 requirements, of this standard. 13.3. The label must bear the following particulars: National regulations may require the information referred to in sections 13.3 and 13.6 of Annex I of the medical devices directive to be in their national language(s) or in another Community language when a device reaches the final user, regardless of whether it is for professional or other use (93/42/EEC, Article 4, paragraph 4). The use of symbols that conform to harmonized standards will mean that there is no need to translate certain information. (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorized representative where the manufacturer does not have a registered place of business in the Community; The full postal addresses may not be necessary if the information is sufficient to contact them, e.g., name or trade name, post code, country. However, the address needs to be sufficient to contact the physical location of the manufacturer and/or the authorized representative, if applicable. The post box alone is not sufficient.
(b) the details strictly necessary to identify the device and the contents of the packaging especially for the For many devices, the identity will be clearly evident to the intended user. Unpackaged devices, devices with SIST EN 1041:2008
EN 1041:2008 (E) 11
Requirements Information Requirements from the Council Directive concerning Medical Devices given in the Essential Requirements in Annex I Guidance users; transparent packaging or those provided only with transit or storage containers may not require further identification. For more complex devices, the identity of the product can be indicated on the device itself or on the packaging or instructions for use, as appropriate. It may be appropriate to list contents and quantity, especially for the users. (c) where appropriate, the word "STERILE"; The word “sterile” by itself is not a symbol and translation may be required. Instead STERILE as given in EN 980 is a symbol and therefore does not require translation. The method of sterilization should also be given, if appropriate, by using the proper symbols. The definitions of “sterile” as given in EN 556-1 and EN 556-2 apply.
The symbol STERILE should be prominent. Where only parts of the device are intended to be sterile, this should be stated e.g., sterile fluid path. (d) where appropriate, the batch code, preceded by the word "LOT", or the serial number; The word “lot” by itself is not a symbol and translation may be required. LOT as given in EN 980 is a symbol and therefore does not require translation.
The symbol LOT can be used to identify batch codes and the symbol
to identify serial numbers. (e) where appropriate, an indication of the date by which the device should be used in safety, expressed as the year and month; The symbol to identify the "use by" date is given in EN 980. This indicates the last month during which the device is intended to be used.
If it is not necessary to give a "use by" date, it may be appropriate to give the date of manufacture using the symbol given in EN 980 in the form YYYY-MM. The latter may be incorporated in the lot number (e.g. LOT 2006-07 1234). (f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community; The symbol ISO 7000/1051 for "Do not re-use" is reproduced in EN 980. (g) if the device is custom made, the words "custom-made device"; National language versions of the Directive also translate the words in quotes. (h) if the device is intended for clinical investigations, the words "exclusively for clinical investigations"; National language versions of the Directive also translate the words in quotes. (i) any special storage and/or handling conditions; Particulars need only be provided for unusual requirements for storage and handling conditions other than those that would normally be expected by the intended user. Information should also be given if storage or handling conditions are critical for the safe and proper performance of the device. Thus it would be generally understood without specific labelling that SIST EN 1041:2008
EN 1041:2008 (E) 12 Requirements Information Requirements from the Council Directive concerning Medical Devices given in the Essential Requirements in Annex I Guidance devices should be protected from extremes of temperature, from weather and from electro-magnetic radiation. However, if a d
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