Design from one real case, then standardise:
| Component | Typical specification | Options | Purpose |
|---|---|---|---|
| Sterile bag / outer pack | Sterile barrier, peel-open | Size per procedure | Aseptic presentation of contents |
| Procedure drape | SMS or film-fabric, fenestrated | Dimension per table | Sterile field and table coverage |
| Table and equipment cover | Fitted or flat | Imaging-compatible | Barrier over equipment |
| Accessory set | Syringes, bowls, gauze, kidney dish | Configured to case | The working sequence |
| Securing and dressing | Catheter securement, dressing | Per access type | Post-procedure fixation |
| Waste bag | Peel-and-stick | With or without | Contained disposal at the table |
Note: the bag is quoted as a configuration; content, sizes and sequence are agreed with your clinical team before the first production run.
Interventional bags are judged on barrier integrity and on reproducibility between shipments:
Yes. We work from your written case list — the items your team opens for a standard procedure and the order they are used in — then agree content, drape dimensions and presentation sequence with the clinical team. The configuration is versioned so later production runs are identical, and items only occasionally needed can be left out and stocked separately.
Packaging is validated to ISO 11607, covering seal strength and peel performance, accelerated aging for shelf life, and distribution or transit testing so the barrier is proven to survive real shipping. Validation reports are available for your technical file.
Yes. Each configuration is versioned and changes require your written agreement before they are introduced. Silent substitution is the failure that erodes clinical trust in procedure packs: the team discovers it with a patient on the table, and the audit record no longer matches what was used.
MOQ depends on component count and customization level. A bag built from standard components with your label carries a lower MOQ than one with custom drape dimensions or bespoke contents, and custom sterile packs are generally quoted at case-quantity volumes. Send the item list and your annual case count and we will confirm the MOQ for that configuration.
Yes, and it is the usual route for a new configuration. A sample pack is assembled so your clinical team can open it, handle the sequence and confirm that drape dimensions, content and presentation order are right before a production run is committed. Changes at sample stage cost nothing; changes after production cost a run.
Each shipment carries the bag lot number and expiry, together with the manufacturer-side documentation: ISO 13485 certificate, CE marking certificate and technical file, declaration of conformity, sterilization reports, ISO 11607 packaging validation and biocompatibility reports. Specimen documentation can be provided before a first order.
Parent and related categories:
Interventional Consumables ·
Anesthesia Puncture Kit ·
Nursing Consumables
OEM & manufacturing:
Custom Procedure Packs ·
OEM & ODM Services ·
Factory Audit & Visit
Regulatory guides for your market:
EU MDR Import Requirements ·
Colombia INVIMA Registration ·
All Regulatory Guides
Who we supply:
Hospital Procurement ·
Become a Distributor
Technical reading:
Interventional Procedure Packs Guide ·
Introducer Sheath Kits Guide ·
ISO 11607 Packaging Validation ·
Pack Design and OR Efficiency
Not sure how much of your tray fits in one Disposable Intervention Surgical Bag?
Send us the items your team gathers for a standard case and your annual case count. We will propose a bag configuration, quote it per case, and build a sample for clinical review.
A sample bag can be built for review before production is committed.