EN 455-1 :2000: Medical gloves for single use – Part 1: Requirements and testing for freedom from holes

Medical gloves for single use – Part 3: Requirements and testing for biological evaluation

DIN EN 455-3:2007-03 (E)
Medical gloves for single use – Part 3: Requirements and testing for biological
evaluation
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Requirements …………………………………………………………………………………………………………………6
5 Test methods ………………………………………………………………………………………………………………….8
6 Test report ………………………………………………………………………………………………………………………9
Annex A (normative) Method for the determination of aqueous extractable proteins in natural
rubber gloves using the modified Lowry assay ………………………………………………………………10
Annex B (informative) Immunological methods for the measurement of natural rubber latex
allergens ……………………………………………………………………………………………………………………….20
Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography (HPLC) 27
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices ……………………………………………..36

Medical gloves for single use – Part 4: Requirements and testing for shelf life determination

DIN EN 455-4:2009-10 (D)
Medizinische Handschuhe zum einmaligen Gebrauch – Teil 4: Anforderungen und
Prüfung zur Bestimmung der Mindesthaltbarkeit; Deutsche Fassung EN 455-4:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Anforderungen………………………………………………………………………………………………………………………6
4.1 Allgemeines ………………………………………………………………………………………………………………………….6
4.2 Haltbarkeitsdauer und Abbaubeständigkeit……………………………………………………………………………7
4.3 Produktänderungen ………………………………………………………………………………………………………………7
4.4 Kennzeichnung……………………………………………………………………………………………………………………..7
4.5 Unversehrtheit der Sterilbarriere ……………………………………………………………………………………………7
4.6 Lagerungsbedingungen…………………………………………………………………………………………………………7
5 Prüfverfahren………………………………………………………………………………………………………………………..8
5.1 Echtzeit-Bestimmung der Haltbarkeitsdauer ………………………………………………………………………….8
5.2 Beschleunigte Bestimmung der Haltbarkeitsdauer…………………………………………………………………8
6 Prüfbericht ……………………………………………………………………………………………………………………………8
Anhang A (normativ) Bestimmung der Haltbarkeitsdauer durch Echtzeit-Stabilitätsprüfungen……………9
Anhang B (informativ) Anleitung zur Durchführung und Analyse von Prüfungen mit
beschleunigter Alterung ………………………………………………………………………………………………………10
Anhang C (informativ) Bestimmung der Haltbarkeitsdauer eines signifikant veränderten Produkts……18
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG „Medizinprodukte“………………….19
Literaturhinweise…………………………………………………………………………………………………………………………….20

Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

Abstract

ISO 3826-2:2008 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users.

The symbols specified in ISO 3826-2:2008 do not replace current national regulatory requirements.

Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. ISO 3826-2:2008 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings.

ISO 3826-2:2008 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling.

ISO 3826-2:2008 may also be of assistance to different stages of the blood supply chain, e.g.:

• distributors of blood collection devices (manual or automated) or other representatives of manufacturers;
• blood centres and distribution centres to simplify and secure the operating procedures.

The use of these symbols is primarily intended for the medical device rather than the therapeutic product.

Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

Abstract

 

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).

The integrated features refer to:

• leucocyte filter;
• pre-donation sampling device;
• top and bottom bag;
• platelet storage bag;
• needle stick protection device.

In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units.

Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

DIN EN ISO 3826-3:2008-03 (E)
Plastics collapsible containers for human blood and blood components – Part 3:
Blood bag systems with integrated features (ISO 3826 -3:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Dimensions and designation …………………………………………………………………………………………..6
5 Design ……………………………………………………………………………………………………………………………8
6 Requirements ……………………………………………………………………………………………………………….10
7 Packaging …………………………………………………………………………………………………………………….11
8 Labelling ……………………………………………………………………………………………………………………….12
9 Anticoagulant and/or preservative solution ……………………………………………………………………13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Device ……………………………………………….14

Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Abstract

ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.

ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer

ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

DIN EN ISO 7886-3:2010-01 (E)
Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixeddose
immunization (ISO 7886-3:200 5)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………6
5 Cleanliness …………………………………………………………………………………………………………………….7
6 Limits for acidity or alkalinity ………………………………………………………………………………………….7
7 Limits for extractable metals …………………………………………………………………………………………..7
8 Lubricant ………………………………………………………………………………………………………………………..7
9 Tolerance on nominal capacity ………………………………………………………………………………………..7
10 Graduated scale ……………………………………………………………………………………………………………..7
11 Barrel ……………………………………………………………………………………………………………………………..8
12 Piston/plunger assembly …………………………………………………………………………………………………8
13 Needle …………………………………………………………………………………………………………………………….8
14 Performance …………………………………………………………………………………………………………………..9
15 Packaging …………………………………………………………………………………………………………………….10
16 Labelling ……………………………………………………………………………………………………………………….10
Annex A (normative) Method for preparation of extracts ……………………………………………………………….13
Annex B (informative) Test method for forces required to operate plunger …………………………………….14
Annex C (normative) Test method for testing auto-disable feature …………………………………………………16
Bibliography …………………………………………………………………………………………………………………………………17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………18

Natural latex rubber condoms – Requirements and test methods (ISO 4074:2002)

DIN EN ISO 4074:2002-07 (D)
Kondome aus Naturkautschuklatex – Anforderungen und Prüfverfahren (ISO
4074:2002); Deutsche Fassung EN ISO 4074:2002
Inhalt Seite
Vorwort ………………………………………………………………………………………………………………………………………..3
Einleitung ………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………….5
2 Normative Verweisungen ………………………………………………………………………………………………..5
3 Begriffe …………………………………………………………………………………………………………………………..5
4 Qualitätsnachweis …………………………………………………………………………………………………………..7
5 Ausführung …………………………………………………………………………………………………………………….7
6 Berstvolumen und Berstdruck …………………………………………………………………………………………8
7 Prüfungen von Stabilität und Haltbarkeitsdauer ………………………………………………………………9
8 Dichtheit ……………………………………………………………………………………………………………………….10
9 Sichtbare Schäden ………………………………………………………………………………………………………..10
10 Unversehrtheit der Verpackung ……………………………………………………………………………………..11
11 Verpackung und Kennzeichnung …………………………………………………………………………………..11
12 Prüfbericht ……………………………………………………………………………………………………………………13
Anhang A (normativ) Stichprobenanweisungen zur Bewertung der Übereinstimmung einer
fortlaufenden Serie von Chargen, die in ausreichender Anzahl vorhanden sind, um die
Übergangsvorschriften anwenden zu können ………………………………………………………………..14
Anhang B (informativ) Stichprobenanweisungen zur Bewertung der Übereinstimmung einzelner
Chargen ………………………………………………………………………………………………………………………..15
Anhang C (normativ) Bestimmung des Gesamtgehalts an Gleitmittel für Kondome in
Einzelpackungen …………………………………………………………………………………………………………..16
Anhang D (normativ) Bestimmung der Länge ………………………………………………………………………………..18
Anhang E (normativ) Bestimmung der Breite ………………………………………………………………………………..20
Anhang F (normativ) Bestimmung der Dicke …………………………………………………………………………………21
Anhang G (normativ) Bestimmung von Berstvolumen und Berstdruck ………………………………………….23
Anhang H (normativ) Behandlung von Kondomen im Wärmeschrank ……………………………………………26
Anhang I (normativ) Bestimmung von Reißkraft und Reißdehnung von Kondomproben ………………..27
Anhang J (normativ) Bestimmung der Haltbarkeitsdauer durch Echtzeitstabilitätsprüfungen …………29

Anhang K (informativ) Leitfaden zur Durchführung und Analyse von beschleunigten
Alterungsprüfungen …………………………………………………………………………………………………….. 31
Anhang L (normativ) Prüfung auf Dichtheit ………………………………………………………………………………….. 35
Anhang M (normativ) Prüfung der Verpackung auf Unversehrtheit ……………………………………………….. 40
Anhang N (normativ) Prüfbericht …………………………………………………………………………………………………. 42
Anhang O (informativ) Empfohlenes Verfahren für die Kalibrierung der für die Bestimmung von
Berstvolumen und Berstdruck verwendeten Geräte zum Aufblasen mit Luft …………………. 43
Anhang P (informativ) Begründungen ………………………………………………………………………………………….. 47
Anhang ZA (informativ) Abschnitte in dieser Europäischen Norm, die grundlegende
Anforderungen oder andere Vorgaben von EU-Richtlinien betreffen ……………………………… 51
Literaturhinweise ………………………………………………………………………………………………………………………… 52

Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

Abstract

ISO 7886-4:2006 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.

ISO 7886-4:2006 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in ISO 7886-4:2006.

NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with ISO 7886-4:2006 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in ISO 7886-4:2006.

DIN EN ISO 7886-4:2010-01 (E)
Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………6
5 Types of syringe ……………………………………………………………………………………………………………..6
6 Cleanliness …………………………………………………………………………………………………………………….6
7 Limits for acidity or alkalinity ………………………………………………………………………………………….6
8 Limits for extractable metals …………………………………………………………………………………………..6
9 Lubricant ………………………………………………………………………………………………………………………..8
10 Tolerance on graduated capacity …………………………………………………………………………………….8
11 Graduated scale ……………………………………………………………………………………………………………..8
12 Barrel ……………………………………………………………………………………………………………………………..8
13 Piston/plunger assembly …………………………………………………………………………………………………8
14 Syringe nozzle/needle ……………………………………………………………………………………………………..9
15 Performance …………………………………………………………………………………………………………………..9
16 Packaging …………………………………………………………………………………………………………………….10
17 Labelling ……………………………………………………………………………………………………………………….10
Annex A (normative) Method for preparation of extracts ……………………………………………………………….13
Annex B (normative) Test method for testing re-use prevention feature for RUP syringes ……………..14
Annex C (informative) Environmental aspects ………………………………………………………………………………15
Bibliography …………………………………………………………………………………………………………………………………16
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………17

EN 12470-1:2000+A1:2009: Clinical thermometers – Part 1: Metallic liquid-in-glass thermometers with maximum device

DIN EN 12470-1:2009-11 (D)
Medizinische Thermometer – Teil 1: Mit metallischer Flüssigkeit gefüllte
Glasthermometer mit Maximumvorrichtung; Deutsche Fassung EN 12470-
1:2000+A1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
1 Anwendungsbereich ……………………………………………………………………………………………………………..4
2 Normative Verweisungen ………………………………………………………………………………………………………4
3 Begriffe …………………………………………………………………………………………………………………………………4
4 Einheit…………………………………………………………………………………………………………………………………..5
5 Thermometerarten…………………………………………………………………………………………………………………5
6 Anforderungen………………………………………………………………………………………………………………………5
6.1 Skale …………………………………………………………………………………………………………………………………….5
6.2 Werkstoff ………………………………………………………………………………………………………………………………7
6.3 Herstellung……………………………………………………………………………………………………………………………7
6.4 Einfluss der Lagerung……………………………………………………………………………………………………………8
6.5 Fehlergrenzen unter Referenzbedingungen……………………………………………………………………………8
6.6 Einfluss der Eintauchzeit……………………………………………………………………………………………………….9
7 Prüfverfahren………………………………………………………………………………………………………………………..9
7.1 Allgemeines ………………………………………………………………………………………………………………………….9
7.2 Verfahren zur Prüfung der Farbbeständigkeit…………………………………………………………………………9
7.3 Prüfverfahren zur Bestimmung der Eispunktdepression ………………………………………………………..9
7.4 Verfahren zur Prüfung der Längenbeständigkeit des Skalenträgers ……………………………………..11
7.5 Verfahren zur Prüfung des Einflusses der Eintauchzeit ………………………………………………………..12
7.6 Verfahren zur Prüfung der Maximumvorrichtung ………………………………………………………………….12
7.7 Verfahren zur Prüfung des Einflusses der Lagerung…………………………………………………………….13
7.8 Verfahren zur Bestimmung der Bruchfestigkeit ……………………………………………………………………13
7.9 Prüfung auf Einhaltung der Fehlergrenzen unter Referenzbedingungen ……………………………….14
8 Bereitstellung von Informationen durch den Hersteller…………………………………………………………15
8.1 Allgemeines ………………………………………………………………………………………………………………………..15
8.2 Kennzeichnung……………………………………………………………………………………………………………………15
8.3 Gebrauchsanweisung ………………………………………………………………………………………………………….15
Anhang A (informativ) Vorgeschlagene Arten von Prüfungen nach den Anforderungen dieser
Norm …………………………………………………………………………………………………………………………………..17
Anhang B (informativ) Hinweis, der in der Gebrauchsanweisung von Quecksilber-
Glasthermometern enthalten sein sollte……………………………………………………………………………….19
B.1 Gesundheits- und Sicherheitsaspekte beim Umgang mit Quecksilber…………………………………..19
B.2 Ausgetretenes Quecksilber………………………………………………………………………………………………….19
Anhang C (informativ) Literaturhinweise…………………………………………………………………………………………..20
Anhang ZA (informativ) !Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42″……………………………………………………21
Anhang ZB (informativ) A-Abweichungen…………………………………………………………………………………………23

EN 12470-2:2000+A1:2009: Clinical thermometers – Part 2: Phase change type (dot matrix) thermometers

DIN EN 12470-2:2009-11 (D)
Medizinische Thermometer – Teil 2: Phasenumschlagthermometer (Punktmatrix);
Deutsche Fassung EN 12470-2:2000+A1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Einheit…………………………………………………………………………………………………………………………………..6
5 Thermometerarten…………………………………………………………………………………………………………………6
6 Anforderungen………………………………………………………………………………………………………………………6
6.1 Skale …………………………………………………………………………………………………………………………………….6
6.2 Beharren der Anzeige ……………………………………………………………………………………………………………7
6.3 Regenerierung ………………………………………………………………………………………………………………………7
6.4 Einfluss der Lagerung……………………………………………………………………………………………………………7
6.5 Fehlergrenzen unter Referenzbedingungen……………………………………………………………………………7
6.6 Ausgelassene Punkte ……………………………………………………………………………………………………………7
6.7 Steril gelieferte Thermometer ………………………………………………………………………………………………..7
6.8 Biologische Verträglichkeit ……………………………………………………………………………………………………8
6.9 Messzeit (klinische) von vorjustierten Thermometern …………………………………………………………….8
6.10 Zusätzliche Anforderungen an wieder verwendbare Thermometer………………………………………….8
6.11 Mechanische Sicherheit…………………………………………………………………………………………………………8
7 Prüfverfahren………………………………………………………………………………………………………………………..8
7.1 Allgemeines ………………………………………………………………………………………………………………………….8
7.2 Prüfung der Einhaltung der Fehlergrenzen …………………………………………………………………………….8
7.3 Verfahren zur Bestimmung des Einflusses der Lagerung……………………………………………………..10
7.4 Verfahren zur Bestimmung der Regenerierungsfähigkeit ……………………………………………………..10
7.5 Verfahren zur Prüfung der Aktivierung benachbarter Dots ……………………………………………………10
7.6 Verfahren zur Prüfung auf ausgelassene Dots ……………………………………………………………………..11
7.7 Verfahren zur Prüfung der Wiederverwendbarkeit ………………………………………………………………..11
8 Bereitstellung von Informationen durch den Hersteller…………………………………………………………12
8.1 Allgemeines ………………………………………………………………………………………………………………………..12
8.2 Kennzeichnung……………………………………………………………………………………………………………………12
8.3 Gebrauchsanweisung ………………………………………………………………………………………………………….12
Anhang A (informativ) Vorgeschlagene Arten von Prüfungen nach den Anforderungen dieser
Norm …………………………………………………………………………………………………………………………………..14
Anhang ZA (informativ) !Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42″……………………………………………………16
Literaturhinweise…………………………………………………………………………………………………………………………….18