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Addendum for the ordering of working materials and substances -Material Safety Purchasing Conditions
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(as of 01/2010)
The following shall be considered to have been agreed upon further to acceptance of the order by the contractor in respect to the supply to Miltenyi Biotec GmbH of technical working materials falling under the regulations concerning the Product and Devices Safety Act [Geräte- und Produktsicherheitsgesetz (GPSG)], and more particularly the working materials listed below:
Pursuant to the GPSG, technical working materials must meet the safety requirements and other prerequisites for marketing formulated on the basis of the GPSG and must not, if used as intended, endanger the life, health or other legal assets of users or third parties as set forth in statutory regulations.
This shall apply in particular to the following:
Personal protection equipment
Pursuant to the Eighth Regulation concerning the Product and Devices Safety Act (Regulation concerning the marketing of personal protection equipment [Verordnung über das Inverkehrbringen von persönlichen Schutzausrüstungen - 8. GPSGV]) personal protection equipment must bear the CE mark. Personal protection equipment must be accompanied at delivery by written information from the manufacturer, drawn up in German, in accordance with Point 1.4 of Appendix II of Directive 89/686/EEC.
Machinery
Machines must comply with the following European Directives as applicable:
- Machine Directive (98/37/EC, and/or, from 29 December 2009, 2006/42/EC instead),
- Low Voltage Directive (2006/95/EC),
- EMC Directive (2004/108/EC),
- other applicable Community Directives,
as well as all harmonised European standards in force. In the absence of harmonised European standards for any machine ordered, the contractor undertakes to follow the German standards and technical specifications published by the [German] Federal Government in the “Machinery Index” [“Verzeichnis Maschinen"] pertaining to the Product and Devices Safety Act. In the event of deviation from harmonised European standards or German standards and technical specifications, the contractor shall document and demonstrate that the same degree of safety was attained in a different manner.
The abovementioned obligations of the contractor include that:
- machines ready for use are fitted with the CE mark,
- machines bearing the CE mark be accompanied by an EC declaration of conformity in accordance with Appendix II A. of the Machine Directive 98/37/EC, and/or, from 29 December 2009 onwards, in accordance with Appendix II 1. A. of Machine Directive 2006/42/EC a declaration in the German language instead, in which all relevant standards complied with are also set forth;
- incomplete machines be accompanied by the manufacturer’s declaration in accordance with Appendix II B. of the Machine Directive 98/37/EC, stating, in accordance with the manufacturer’s scope of delivery, conformity with all other applicable Directives, and/or, from 29 December 2009 onwards, an installation statement concerning the installation of an incomplete machine in accordance with Appendix II 1. B. of Machine Directive 2006/42/EC instead;
- a safety component within the meaning of the Machine Directive be accompanied by the EC declaration of conformity in accordance with Appendix II C. of the Machine Directive 98/37/EC, and/or, from 29 December 2009 onwards, within the meaning of the Machine Directive, that the EC declaration of conformity and the CE mark and if applicable the type approval or comprehensive quality assurance measures according to Machine Directive 2006/42/EC be provided and/or proven instead;
- for technical working materials potentially subject to EC type approvals, the certification of an approved Testing and Certification Body be submitted;
- instructions for use pursuant to Appendix I No. 1.7.4 of Machine Directive 98/37/EC, and/or, from 29 December 2009 onwards, pursuant to Machine Directive 2006/42/EC instead, drawn up in German, also be supplied; in particular, the stipulated noise emission values are to be determined and documented. This shall also apply to incompletely delivered machines,
- to machines or incomplete machines, where Technical Documentation in accordance with Appendix V of Machine Directive 98/37/EC, and/or, from 29 December 2009 onwards, in accordance with Appendix VII of Machine Directive 2006/42/EC instead, shall also be supplied
The following additional safety relevant documents for the machine shall also be made available by the contractor:
- Test certificates in respect to electrical safety (grounding conductor resistance, insulation resistance) for machines when installed by the contractor at Miltenyi Biotec GmbH;
- Hazard analysis in accordance with Appendix I of the Machine Directive 98/37/EC, and/or, from 29 December 2009 onwards, a risk assessment in accordance with Appendix I 1 of Machine Directive 2006/42/EC.
For machines assembled by the contractor at Miltenyi Biotec GmbH it is agreed that following assembly and together with a representative of the pertinent technical department of Miltenyi Biotec GmbH the machine shall be subjected to a safety test and the appropriate report shall be drawn up. The following shall, in particular, be verified:
- the completeness of protective equipment,
- the efficacy of protective equipment,
- the completeness of the accompanying technical documentation.
Incomplete machines:
The contractor shall be under the obligation to:
- accurately describe its scope of performance and delivery,
- provide Miltenyi Biotec GmbH all necessary interface information to enable it to assess, plan and implement the scope of performance as concerns functional and safety add-ons,
- supply technical documentation pursuant to Appendix V of Machine Directive 98/37/EC in the scope necessary to render compliant a machine delivered not ready for use,
- in accordance with Article 13 Paragraph 2 of Machine Directive 2006/42/EC, from 29 December 2009 onwards provide, instead, the assembly instructions in addition to the declaration of installation.
The above points shall also apply in regard to orders for used machines if such machines are imported into the European Economic Area from a third country.
As concerns orders for concatenated machines, the contractor shall assume responsibility for conformity unless otherwise agreed upon.
Electrical operating equipment
Pursuant to the First Regulation concerning the Product and Devices Safety Act (Regulation concerning the marketing of electrical equipment for use within specific voltage ranges [Verordnung über das Inverkehrbringen von elektrischer Betriebsmittel zur Verwendung innerhalb bestimmter Spannungsgrenzen - 1. GPSGV]) such electrical equipment must bear the CE mark.
Simple pressure vessels
Simple pressure vessels (serial production welded containers for air or nitrogen with a maximum operating pressure of 30 bar and a maximum internal pressure product (Pressure x Volume) of 10,000 bar x I (further prerequisites for the presence of a simple pressure vessel cf. 6. GSGV)) must, pursuant to the Sixth Regulation concerning the Product and Devices Safety Act (Regulation concerning the marketing of simple pressure vessels [Verordnung über das Inverkehrbringen von einfachen Druckbehältern - 6. GPSGV]) must be provided with the information pursuant to Appendix II No. 1 of Directive 87/404/EEC and the CE mark. Simple pressure vessels must be accompanied by operating instructions drawn up in German by the manufacturer in accordance with Appendix II No. 2 of Directive 87/404/EEC.
Gas fired equipment
Pursuant to the Seventh Regulation concerning the Product and Devices Safety Act (Gas Burning Equipment - 7. GPSGV]) gas fired equipment must bear the CE mark. Such equipment must be accompanied by the documentation, drawn up in German, set forth in Appendix I No. 1.2 of Directive 90/396/EEC.
The following shall considered to be agreed upon as concerns supply of technical working materials and parts thereof not falling under the regulations pertaining to the GPSG:
Technical working materials must, both according to the state of the art and pursuant to worker protection and accident prevention regulations, possess properties such that, when the materials are used as intended, users and third parties are protected against any and all hazards to life or health to the extent possible in view of such intended use. Any deviation from this rule requires a certification warranting the same level of safety.
The following shall be considered to have been agreed upon in regard to the supply of hazardous materials:
The hazardous material or preparation / mixture must, pursuant to the Regulation for Hazardous Materials Protection (Gefahrstoffverordnung - GefStoffV) be accompanied, at the latest at the first delivery, by a Material Safety Data Sheet in compliance with the European Directive or Regulation in effect at the time of such delivery (material and/or preparation Directive, and/or REACH Regulation), drawn up in German and dated. With repeat orders and if the product has been modified, the supplier must, of its own accord, provide a current Material Safety Data Sheet.
The above obligations are an integral part of the Agreement. Non-compliance therewith shall constitute a default in proper performance. Without prejudice to any warranties, we reserve the right to assert further claims for compensation resulting from consequences arising out of such default.
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