| ISO 5832-9 Second edition 2007-06-15 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 8-150 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Materials |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.
NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
| Regulation Number | Device Name | Device Class | Product Code |
| Metallic components of all implantables | |||
| No product code information listed for §888.3XXX, Metallic components of all implantables | |||
| §872.5500 | Headgear, Extraoral, Orthodontic | Class 2 | DZB |
| §872.5410 | Band, Elastic, Orthodontic | Class 1 | ECI |
| §872.5410 | Band, Material, Orthodontic | Class 1 | DYO |
| §872.5410 | Band, Preformed, Orthodontic | Class 1 | ECM |
| §872.5410 | Bracket, Metal, Orthodontic | Class 1 | EJF |
| §872.5410 | Bracket, Metal, Orthodontic, Reprocessed | Class 1 | NQS |
| §872.5410 | Clamp, Wire, Orthodontic | Class 1 | ECN |
| §872.5410 | Retainer, Screw Expansion, Orthodontic | Class 1 | DYJ |
| §872.5410 | Spring, Orthodontic | Class 1 | ECO |
| §872.5410 | Tube, Orthodontic | Class 1 | DZD |
| §872.5410 | Wire, Orthodontic | Class 1 | DZC |
| §872.4880 | Screw, Fixation, Intraosseous | Class 2 | DZL |
| §872.4760 | External Mandibular Fixator And/Or Distractor | Class 2 | MQN |
| §872.4760 | Implant, Transmandibular | Class 2 | MDL |
| §872.4760 | Plate, Bone | Class 2 | JEY |
| §872.4600 | Lock, Wire, And Ligature, Intraoral | Class 2 | DYX |
| §872.4565 | Accessories, Retractor, Dental | Class 1 | EIF |
| §872.4565 | Aligner, Bracket, Orthodontic | Class 1 | ECQ |
| §872.4565 | Broach, Endodontic | Class 1 | EKW |
| §872.4565 | Burnisher, Operative | Class 1 | EKJ |
| §872.4565 | Carrier, Amalgam, Operative | Class 1 | EKI |
| §872.4565 | Chisel, Bone, Surgical | Class 1 | EML |
| §872.4565 | Chisel, Osteotome, Surgical | Class 1 | EMM |
| §872.4565 | Condenser, Amalgam And Foil, Operative | Class 1 | EKG |
| §872.4565 | Curette, Endodontic | Class 1 | EKT |
| §872.4565 | Curette, Operative | Class 1 | EKE |
| §872.4565 | Curette, Periodontic | Class 1 | EMS |
| §872.4565 | Curette, Surgical, Dental | Class 1 | EMK |
| §872.4565 | Driver, Band, Orthodontic | Class 1 | ECT |
| §872.4565 | Elevator, Surgical, Dental | Class 1 | EMJ |
| §872.4565 | Excavator, Dental, Operative | Class 1 | EKC |
| §872.4565 | Explorer, Operative | Class 1 | EKB |
| §872.4565 | File, Bone, Surgical | Class 1 | EMI |
| §872.4565 | File, Margin Finishing, Operative | Class 1 | EKA |
| §872.4565 | File, Periodontic | Class 1 | EMR |
| §872.4565 | File, Pulp Canal, Endodontic | Class 1 | EKS |
| §872.4565 | Forceps, Articulation Paper | Class 1 | EFK |
| §872.4565 | Forceps, Dressing, Dental | Class 1 | EFL |
| §872.4565 | Forceps, Rongeur, Surgical | Class 1 | EMH |
| §872.4565 | Forceps, Tooth Extractor, Surgical | Class 1 | EMG |
| §872.4565 | Gauge, Depth, Instrument, Dental | Class 1 | EIL |
| §872.4565 | Handle, Instrument, Dental | Class 1 | EJB |
| §872.4565 | Hemostat, Surgical | Class 1 | EMD |
| §872.4565 | Hoe, Periodontic | Class 1 | EMQ |
| §872.4565 | Instrument, Contouring, Matrix, Operative | Class 1 | EKF |
| §872.4565 | Instrument, Cutting, Operative | Class 1 | EKD |
| §872.4565 | Instrument, Filling, Plastic, Dental | Class 1 | EIY |
| §872.4565 | Instrument, Hand, Calculus Removal | Class 1 | ELA |
| §872.4565 | Instrument, Ligature Tucking, Orthodontic | Class 1 | ECP |
| §872.4565 | Instruments, Dental Hand | Class 1 | DZN |
| §872.4565 | Knife, Margin Finishing, Operative | Class 1 | EJZ |
| §872.4565 | Knife, Periodontic | Class 1 | EMO |
| §872.4565 | Lapping Tool Kit | Class 1 | NYG |
| §872.4565 | Marker, Periodontic | Class 1 | EMP |
| §872.4565 | Mirror, Mouth | Class 1 | EAX |
| §872.4565 | Parallelometer | Class 1 | EGI |
| §872.4565 | Plier, Orthodontic | Class 1 | JEX |
| §872.4565 | Pliers, Operative | Class 1 | EJY |
| §872.4565 | Plugger, Root Canal, Endodontic | Class 1 | EKR |
| §872.4565 | Preparer, Root Canal Endodontic | Class 1 | EKQ |
| §872.4565 | Probe, Periodontic | Class 1 | EIX |
| §872.4565 | Punch, Biopsy, Surgical | Class 1 | EME |
| §872.4565 | Pusher, Band, Orthodontic | Class 1 | ECS |
| §872.4565 | Reamer, Pulp Canal, Endodontic | Class 1 | EKP |
| §872.4565 | Remover, Crown | Class 1 | EIS |
| §872.4565 | Retainer, Matrix | Class 1 | JEP |
| §872.4565 | Retractor, All Types | Class 1 | EIG |
| §872.4565 | Scaler, Periodontic | Class 1 | EMN |
| §872.4565 | Scissors, Collar And Crown | Class 1 | EIR |
| §872.4565 | Scissors, Surgical Tissue, Dental | Class 1 | EGN |
| §872.4565 | Setter, Band, Orthodontic | Class 1 | ECR |
| §872.4565 | Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | EKK |
| §872.4565 | Syringe, Irrigating (Dental) | Class 1 | EIB |
| §872.4565 | Syringe, Periodontic, Endodontic, Irrigating | Class 1 | EIC |
| §872.4565 | Syringe, Restorative And Impression Material | Class 1 | EID |
| §872.4565 | Unit, Syringe, Air And/Or Water | Class 1 | ECB |
| §872.4200 | Handpiece, Air-Powered, Dental | Class 1 | EFB |
| §872.4200 | Handpiece, Belt And/Or Gear Driven, Dental | Class 1 | EFA |
| §872.4200 | Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | EGS |
| §872.4130 | Drill, Dental, Intraoral | Class 1 | DZA |
| §872.4120 | Drill, Bone, Powered | Class 2 | DZI |
| §872.4120 | Driver, Wire, And Bone Drill, Manual | Class 2 | DZJ |
| §872.4120 | Handpiece, Rotary Bone Cutting | Class 2 | KMW |
| §872.4120 | Saw, Bone, Ac-Powered | Class 2 | DZH |
| §872.3900 | Teeth, Artificial, Posterior With Metal Insert | Class 1 | ELJ |
| §872.3810 | Post, Root Canal | Class 1 | ELR |
| §872.3740 | Pin, Retentive And Splinting, And Accessory Instruments | Class 1 | EBL |
| §872.3580 | Teeth, Preformed Gold Denture | Class 1 | ELN |
| §872.3360 | Cusp, Preformed | Class 1 | EHQ |
| §872.3350 | Cusp, Gold And Stainless Steel | Class 1 | ELO |
| §872.3330 | Crown, Preformed | Class 1 | ELZ |
| §872.3285 | Clasp, Preformed | Class 1 | EHP |
| §872.3240 | Bur, Dental | Class 1 | EJL |
| §872.3165 | Attachment, Precision, All | Class 1 | EGG |
| §872.3130 | Anchor, Preformed | Class 1 | EJX |
| There is no relevant guidance developed at this time. |