Risk Assessment Form

Checklist for medical and pharma applications

Customer name
Customer number
Name:
Contact person
E-Mail:

Phone:

OEM-Info
Name:
OEM contact person
E-Mail:

Phone:

1. Detailed application description

1.1 Product / Project Name

1.2 Can you provide pictures or drawings to visualize the application?

 yes  no

1.3 Area of use

 Packaging  Medical Devices
 In Vitro Diagnostics  Other

2. Market areas
 Americas  Europe, Africa, Middle East  Asia / Pacific

3. Does the TPE have contact to a medium which is inserted into the body?
 no  yes
If ‘yes’: Name: Percentage: Duration:

3.1 Kind of healthcare compliance confirmation required?

 none
 USP class VI
 ISO 10993-5
 Other:

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 Risk Assessment Form
Checklist for medical and pharma applications

3.2 Medical Classification after MDD93/42 class; IPVV 98/79EC

 class I  class IIa  class IIb  class III

3.3 Method of use

 single use  multi use

3.4 Direct blood contact

 no  yes duration:

3.5 Body contact

 no  yes duration:

3.6 Time of use (according MDD93/42)

 up to 24h  up to 30 days  over 30 days

4. Color requirements
 none  nature  transparent  colored: RAL/Pantone:

5. Is a hard/soft adhesion required?

 no  yes, adhesion is required to:

6. Sterilisation – Methods and conditions?

 none
 Eto-gas
 Hot steam Conditions (Temperature, Holding time, no. of cycles):

 Radiation Conditions (Dose in kGy; no. of cycles):

 Other

7. Specific demands / technical specifications

 none  compression-set
 re-sealing  other

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 Risk Assessment Form
Checklist for medical and pharma applications

8. Contact and storage times? (Lifespan of the product)

9. Estimated consumption of TPE (tons p.a.)?

10. Customer information – to be filled out by the customer of KRAIBURG TPE

Company:

Name:

Date Signature / Company stamp

Internal handling comment KRAIBURG TPE

(to be filled out by KRAIBURG TPE, local market manager for the medical/pharma market)

PISA project-no :
Customer No. :
Sales team & sales person :
Risk-Check  approved  refused
Checked by (name) :

Date Signature

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